Medline Medical Kits and Trays Recalled for Potential Sterility Failure
Medline Industries is recalling certain medical kits and trays that may contain non-sterile solutions. Healthcare facilities should discontinue use of affected batches to prevent patient exposure to potential contamination.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall, which per the severity rubric requires a minimum score of 4. No illnesses, injuries, or deaths are reported in the source; the potential hazard is lack of sterility in component solutions. The score of 4 reflects the serious nature of sterility failure in medical kits while acknowledging the absence of adverse health events.
Plain-English summary
Medline Industries, LP is recalling certain sterile medical kits, trays, and packs that were manufactured using specific component lots from Nurse Assist. The affected products include Catheter Lab CDS trays, Pediatric Port A Catheter trays, Radiology procedure packs, and Port Access packs.
The recall was initiated because certain component lots of 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP, and Saline Flush Syringe may lack sterility. If these components are non-sterile, the assembled solutions could be contaminated, potentially exposing patients to infection or other complications during medical procedures.
The recall encompasses 385,028 units distributed nationwide throughout the United States, as well as to Puerto Rico, Canada, the United Arab Emirates, and Panama. Specific lot numbers are identified for each product type, enabling healthcare facilities to identify and isolate affected inventory.
Healthcare facilities should immediately discontinue use of the affected kits and trays. Customers should contact Medline Industries for instructions on return or replacement of recalled items.
The recalled product
- Product
- MEDLINE Kits, trays, and packs labeled as follows: a) CATH LAB CDS, REF CDS840228F; b) PEDIATRIC PORT A CATH TRAY, REF DYNDC2128B; c) PK, RADIOLOGY, REF DYNJ44087A; d) PORT ACCESS PACK-LF, REF DYNJ0352159C; DYNJ0352159D
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- lack-of-sterility
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) REF CDS840228F
- UDI/DI 40889942778547 (case)
- 10889942778546 (unit)
- Lot Numbers: 22CLA155
- 22FLA788
- 22GLA774
- 22KLB047
- 23CLA672
- 23CLA832
- 23ELA032
- 23FLA055
- 23FLA663
- b) REF DYNDC2128B
- UDI/DI 40195327249114 (case)
- 10195327249113 (unit)
- Lot Numbers: 22IBG388
- c) REF DYNJ44087A
- UDI/DI 40889942561804 (case)
- 10889942561803 (unit)
- Lot Numbers: 21112457
Distribution
Distributed nationwide across the United States.
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