MEDLINE medical convenience kits recalled for defective component
Medline is recalling medical convenience kits (CLEAN CLOSING PACK and CLEAN CLOSURE PACK GREEN) distributed nationwide because they contain a SafeAir Smoke Evacuation Pencil component that was recalled by Stryker.
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 medical device convenience kits containing a component (SafeAir Smoke Evacuation Pencil) that was recalled by Stryker. The presence of a recalled component in a medical device product represents a risk-of-harm scenario where injury has not yet been reported, meeting the rubric criterion for High severity.
Plain-English summary
Medline Industries is recalling two medical convenience kits: CLEAN CLOSING PACK (REF DYNJ80686A) and CLEAN CLOSURE PACK GREEN (REF DYNJ84667). These kits were manufactured using certain lots of the SafeAir Smoke Evacuation Pencil, a component that was subsequently recalled by Stryker. The recall was issued by the FDA as a Class II recall.
A total of 66 units were affected and distributed nationwide in the United States. The affected lot numbers are: 24CBR604, 24CBA831 (for REF DYNJ80686A), and 23KBO980 (for REF DYNJ84667). Consumers and healthcare facilities that received these kits should immediately stop using them and contact Medline for further instructions.
The recalled product
- Product
- MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN CLOSURE PACK GREEN, REF DYNJ84667
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 66
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 (7)
- 1) REF DYNJ80686A
- UDI/DI 10195327560645 (each) 40195327560646 (case)
- Lot Numbers: 24CBR604
- 24CBA831
- 2) REF DYNJ84667
- UDI/DI 10195327396329 (each) 40195327396320 (case)
- Lot Numbers: 23KBO980
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 28 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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