Surgical Convenience Kits Recalled for Non-Sterile Components and Endotoxin Risk
See DocMan surgical convenience kits are recalled for containing non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination. Kits were distributed in the US, UAE, and Canada.
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 involving non-sterile surgical components with potential endotoxin contamination. While no illnesses or injuries have been reported, the hazard is significant due to the high-risk nature of endotoxins in surgical applications and direct contact with body tissues during use.
Plain-English summary
See DocMan surgical convenience kits manufactured by Medline Industries, LP (Northfield) are being recalled. These custom kits contain Codman Surgical Patties and Surgical Strips.
The components were manufactured non-sterile and have the potential for endotoxin contamination. Endotoxins are bacterial toxins that can cause serious complications if introduced into the body during surgical procedures.
Approximately 65,310 units of the affected kits have been distributed worldwide, including the United States, the United Arab Emirates, and Canada. Multiple product reference numbers and lot numbers are affected.
Healthcare facilities that have received these kits should discontinue use immediately. Customers should contact Medline Industries for instructions on returns or replacements. No illnesses or injuries related to this recall have been reported to date.
The recalled product
- Product
- See DocMan
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Hazard
- endotoxin
- non-sterile
- 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)
- 1) REF CDS930177C
- UDI/DI 10889942810949 (EA) 40889942810940 (CS)
- Lot Numbers: 19BBO293
- 19CBI818
- 19EBC020
- 19IBS311
- 19JBP366
- 19LBY043
- 19VBE320
- 20CBD448
- 21ABE744
- 21BBN653
- 2) REF CDS982054V
- UDI/DI 10193489552799 (EA) 40193489552790 (CS)
- Lot Numbers: 19BBJ530
- 19CBL695
- 19EBN805
- 19EBZ133
- 3) REF CDS982683X
- UDI/DI 10198459064548 (EA) 40198459064549 (CS)
Distribution
Distributed nationwide across the United States.
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