Medline surgical procedure kits recalled for potential endotoxin contamination
Medline is recalling three custom surgical procedure kits due to non-sterile Codman Surgical Patties and Strips that pose a potential endotoxin contamination risk. The affected kits were distributed in the US, Canada, and the UAE.
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 a Class II medical device recall for a potential endotoxin contamination hazard in surgical kits used in invasive procedures. However, the contamination is described as potential rather than confirmed, and no illnesses or injuries are reported. Per the rubric, theoretical hazards without reported illness are scored at most as High.
Plain-English summary
Medline Industries, LP is recalling three custom medical procedure kits: PANENDOSCOPY-LF (REF DYNJ36728C), ENDOSCOPIC SINUS PACK (REF DYNJ40644A), and ENDO SINUS PACK (REF DYNJ66449). Approximately 1,086 units are affected.
The kits are being recalled because they contain non-sterile Codman Surgical Patties and Surgical Strips, which have the potential for endotoxin contamination. Endotoxin poses a health risk in sterile medical device applications, particularly in invasive surgical procedures such as endoscopy and sinus surgery.
The affected kits were distributed worldwide, including in the US, Canada, and the UAE. No illnesses or injuries have been reported to date in connection with these kits.
The recalled product
- Product
- Medline custom medical procedure kits labeled as: 1) PANENDOSCOPY-LF, REF DYNJ36728C; 2) ENDOSCOPIC SINUS PACK, REF DYNJ40644A; 3) ENDO SINUS PACK, REF DYNJ66449.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 1,086
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 DYNJ36728C
- UDI/DI 10193489265910(EA) (CS)
- Lot Numbers: 20EBK304
- 20HBL260
- 20LBA831
- 20WBG513
- 21DBK481
- 21KBO816
- 22BBJ543
- 22FBD924
- 22HBR956
- 22KBJ095
- 23BBF230
- 23FBG752
- 23HBI340
- 23IBD038
- 24CBG736
- 24GBJ933
- 2) REF DYNJ40644A
- UDI/DI 10193489292176(EA) (CS)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 18 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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