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.
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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Integra LifeSciences
Class I - Dangerous
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.
Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Integra LifeSciences
Class I - Dangerous
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.
Colonoscope, Model Number PCF-H180AL.
Olympus Corporation of the Americas
Class I - Dangerous
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Colonoscope, Model Number CF-HQ190L.
Olympus Corporation of the Americas
Class I - Dangerous
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
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.
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2
Vyaire Medical
Class I - Dangerous
Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.
MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C; c) UMBILICAL VESSEL INSERTION, REF UVT1170; d) UMBILICAL VESSEL INSERTION, REF UVT1170H
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
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.
Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A; b) LCPH LAB DRAW KIT, REF DYNDH1641A; c) LCPH LAB DRAW KIT, REF DYNDH1641AH; d) OB LAB COLLECTION KIT, REF DYNDH1719A;
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
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.
Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Integra LifeSciences
Class I - Dangerous
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.
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.
AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F
Vyaire Medical
Class I - Dangerous
Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.
Class I - Dangerous
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.
Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
Integra LifeSciences
Class I - Dangerous
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.
Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.
EMD Millipore
Class I - Dangerous
This IVD is colorless. A customer complaint was received noting it appeared pink. A review of inventory confirmed additional stock appeared pink.
Colonoscope, Model Number PCF-Q180AL.
Olympus Corporation of the Americas
Class I - Dangerous
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the brain.
Integra LifeSciences
Class I - Dangerous
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.
AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2
Vyaire Medical
Class I - Dangerous
Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.
Centurion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, REF DYNDA2271
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
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.
MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT, REF DYNDJ1129; b) TRACH CARE TRAY, REF DYNDJ1057A; c) TRACHEOSTOMY CARE KIT, REF DYNDA1893A; d) TRACH CARE TRAY, REF DYNDA1482
MEDLINE INDUSTRIES, LP - Northfield
Class I - Dangerous
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.