MEDLINE Port Insertion Pack Recalled for Defective Component
Medline is recalling 44 PORT INSERTION PACK kits nationwide. These kits contain SafeAir Smoke Evacuation Pencil components that were previously recalled by Stryker.
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: FDA Class II recall with no reported illnesses or injuries. The specific nature of the component defect is not described in the source, making the hazard theoretical rather than confirmed. This qualifies as a risk-of-harm medical device product.
Plain-English summary
Medline Industries, LP is recalling MEDLINE PORT INSERTION PACK kits (REF DYNJ81597) distributed nationwide in the United States. The recall affects 44 units with lot numbers 22IBF254 and 23BBO299. These convenience kits contain SafeAir Smoke Evacuation Pencil components that were previously recalled by Stryker.
The defect in the SafeAir Smoke Evacuation Pencil components is the basis for this recall. The U.S. Food and Drug Administration classified this as a Class II recall. Customers with affected lot numbers should contact Medline Industries regarding the recall and appropriate next steps.
The recalled product
- Product
- MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 44
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)
- REF DYNJ81597
- UDI/DI 10195327124007 (each) 40195327124008 (case)
- Lot Numbers: 22IBF254
- 23BBO299
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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