Sterile surgical kits recalled due to weak pouch seals risking contamination
Medline sterile surgical kits are being recalled nationwide due to weak seals in the Pure Pouch component that may allow sterility breach. The recall affects 12,588 units distributed across 23 states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of sterile surgical kits with weak seals that could compromise sterility. No illnesses or injuries have been reported, and the hazard is theoretical. Per the rubric, risk-of-harm products without reported injuries score as High (3).
Plain-English summary
Medline Industries is recalling sterile surgical convenience kits (model Retrograde PK-22025203-LF, Pack #DYNJ47873L) due to weak seals in the Pure Pouch component.
The Pure Pouch seals in these kits may breach, potentially compromising the sterility of the surgical instruments contained within.
The recall affects 12,588 sterile kits distributed nationwide to healthcare facilities in Alabama, California, Colorado, Connecticut, Florida, Illinois, Indiana, Maryland, Minnesota, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, and Wyoming. The affected kits have lot number 23KBW512 with an expiration date of August 31, 2027.
The recalled product
- Product
- Sterile surgical convenience kit: Medline Retrograde PK-22025203-LF, Pack #DYNJ47873L, containing a Pure Pouch with component Sterile Curved Kelly Hemostat, Reorder #66175.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Hazard
- weak-seal
- sterility-breach
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 (4)
- Pack #DYNJ47873L - lot numbers 23KBW512
- exp. 8/31/2027
- UDI-DI each-10195327506896
- UDI-DI case-40195327506897.
Distribution
Distributed nationwide across the United States.
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