March 6, 2024Medical DevicesFDA
Integra LifeSciences Corp. recalls Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ven
Hazard: A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
March 6, 2024Medical DevicesFDA
GRAPHENANO DENTAL SL recalls GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112;
Hazard: Machining error on cams renders the device unusable.
March 6, 2024Medical DevicesFDA
NxStage MDS Corporation recalls NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and r
Hazard: Product is recalled due to reports of blood leaking or spraying from the arterial line on the cartridge.If this failure occurs, a patient may experience uncontrolled blood loss or a healthcare professional could be exposed to infectious patient blood.
March 6, 2024Medical DevicesFDA
Abbott Molecular, Inc. recalls Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
Hazard: Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
March 6, 2024Medical DevicesFDA
Abbott Molecular, Inc. recalls In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PT
Hazard: Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
March 6, 2024Medical DevicesFDA
Abbott Molecular, Inc. recalls In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319
Hazard: Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
March 6, 2024Medical DevicesFDA
EMD Millipore Corporation recalls Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.
Hazard: This IVD is colorless. A customer complaint was received noting it appeared pink. A review of inventory confirmed additional stock appeared pink.
March 6, 2024Medical DevicesFDA
Medagent Inc recalls Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 0
Hazard: Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is transferred to the spatula, which is attached to the holding arm.
March 6, 2024Medical DevicesFDA
Zyno Medical LLC recalls Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and
Hazard: When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a low one, causing potential delays in therapy and in extreme cases, associated risk of organ failure or death
March 6, 2024Medical DevicesFDA
Alphatec Spine, Inc. recalls IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x
Hazard: Due to reports of intraoperative graft bolt implantation breakages.
March 6, 2024Medical DevicesFDA
Medtronic Neurosurgery recalls Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile E
Hazard: Potential for catheter disconnection from the patient line stopcock connectors.
March 6, 2024Medical DevicesFDA
Medtronic Neurosurgery recalls Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Ster
Hazard: Potential for catheter disconnection from the patient line stopcock connectors.
March 6, 2024Medical DevicesFDA
Medtronic Neurosurgery recalls Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Ster
Hazard: Potential for catheter disconnection from the patient line stopcock connectors.
March 6, 2024Medical DevicesFDA
Medtronic Neurosurgery recalls Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used
Hazard: Potential for catheter disconnection from the patient line stopcock connectors.
March 6, 2024Medical DevicesFDA
Medtronic Neurosurgery recalls Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used
Hazard: Potential for catheter disconnection from the patient line stopcock connectors.
March 6, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, REF DYNDA2271
Hazard: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
March 6, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion Kits, trays, and packs labeled as follows: BREAST BIOPSY KIT, REF MNS4360
Hazard: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
March 6, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion Kits, trays, and packs labeled as follows: a) A C DAILY WET KIT, REF DM405A; b) BWH DAILY DRIVELINE MGMT
Hazard: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
March 6, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion Kits, trays, and packs labeled as follows: LACERATION TRAY, REF ST11670A
Hazard: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
March 6, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF IVS1860B; b) NEONATAL PICC LINE INSE
Hazard: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
March 6, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion Kits, trays, and packs labeled as follows: LATEX FREE TRACHEOSTOMY CARE TRAY, REF TC7170
Hazard: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
March 6, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion Kits, trays, and packs labeled as follows: a) BASIC PROCEDURE TRAY, REF MNS13600; b) BWH DAILY DRIVELINE
Hazard: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
March 6, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010
Hazard: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
March 6, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIA
Hazard: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
March 6, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A
Hazard: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
March 6, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Kits, trays, and packs labeled as follows: a) KIT,SUCTION CATH,10FR W/WATER, REF DYND41470; b) KIT,SUCTION
Hazard: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
March 6, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Kits, trays, and packs labeled as follows: a) ANTERIOR PACK, REF DYNJ64814A; b) ARTHROGRAM TRAY, REF DYNDH1
Hazard: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
March 6, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Kits, trays, and packs labeled as follows: a) CATARACT PACK, REF VAL011CTASD; b) CATARACT PACK, REF DYNJ688
Hazard: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
March 6, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Kits, trays, and packs labeled as follows: a) D&C CDS, REF CDS983911J; b) D&C PACK, REF DYNJ67214F; c) D&
Hazard: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
March 6, 2024Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Medline Kits, trays, and packs labeled as follows: C-SECTION, REF DYNJ904653G
Hazard: Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.