Medline Convenience Kits Recalled Due to Defective Component
Medline Industries is recalling 70 convenience kits containing SafeAir Smoke Evacuation Pencil components that were subsequently recalled by Stryker. The affected product types are General Endoscopy Pack and Endo Bladder Pack.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 FDA Class II medical device recall with no reported illnesses, injuries, or deaths. The defective smoke evacuation pencil component is used in surgical procedures, making this a risk-of-harm product. Per the severity rubric, risk-of-harm products without reported injuries score 3 (High).
Plain-English summary
Medline Industries, LP is recalling 70 convenience kits that were manufactured with SafeAir Smoke Evacuation Pencil components supplied by Stryker. These pencil components were subsequently recalled by Stryker for unspecified safety reasons.
Two types of Medline convenience kits are affected: GENERAL ENDOSCOPY PACK (Reference DYNJ44673G, Lot 23GDB181) and ENDO BLADDER PACK (Reference DYNJ49672L, Lot Numbers 22GDB352 and 22FDC210). The kits have been distributed nationwide throughout the United States.
The specific nature of the defect in the SafeAir Smoke Evacuation Pencil is not described in the recall notice. No information regarding recommended user actions is provided in the source material. Healthcare facilities that received these lot numbers should contact Medline Industries for further guidance.
The recalled product
- Product
- MEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44673G; 2) ENDO BLADDER PACK, REF DYNJ49672L
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 70
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 DYNJ44673G
- UDI/DI 10195327127473 (each) 40195327127474 (case)
- Lot Numbers: 23GDB181
- 2) REF DYNJ49672L
- UDI/DI 10195327127794 (each) 40195327127795 (case)
- Lot Numbers: 22GDB352
- 22FDC210
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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