MEDLINE kits and trays recall: Sterility Concern
MEDLINE kits and trays, labeled as: a) SUCTION CATH 10FR KIT W/SALINE, REF DYND41470SA, DYND41470SAH; b) TRACH CARE TRAY, REF DYNDA1931B, DYNDA1931BH
Why was MEDLINE kits and trays recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a) REF DYND41470SA, UDI/DI 40884389338705 (case), 10884389338704 (unit), Lot Numbers: 22HBD360, 22IBA256, 23ABU349, 23CBG160, 23GBV051, 23IBT355; REF DYND41470SAH; UDI/DI - same as DYND41470SA, Lot Numbers: 22HBD360, 22IBA256, 23ABU349, 23CBG160, 23GBV051, 23IBT355; b) REF DYNDA1931B, UDI/DI 40195327277360 (case), 10195327277369 (unit), Lot Numbers: 22LMC118, 22LMC126, 23EMB086; REF DYNDA1931BH, UDI/DI - same as DYNDA1931B, Lot Numbers: 22LMC118, 22LMC126, 23EMB086
- Product
- MEDLINE kits and trays, labeled as: a) SUCTION CATH 10FR KIT W/SALINE, REF DYND41470SA, DYND41470SAH; b) TRACH CARE TRAY, REF DYNDA1931B, DYNDA1931BH
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 385028 units
- Distribution
- Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
- Recall date
- March 6, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)