Medline Colon Wound Closure Packs recalled due to defective component
Medline is recalling Colon Wound Closure Packs (REF DYNJ52141B) because they were manufactured using SafeAir Smoke Evacuation Pencils that were recalled by Stryker. The kits have been distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall without reported illnesses or injuries. The recall is precautionary due to use of a previously recalled component. Class II designation indicates potential risk, but absence of reported harm and unspecified hazard warrant moderate rather than high severity.
Plain-English summary
Medline Industries is recalling Colon Wound Closure Packs labeled as REF DYNJ52141B. These medical convenience kits were manufactured using certain lots of SafeAir Smoke Evacuation Pencils, which were subsequently recalled by Stryker, the component manufacturer.
The affected lot numbers are 23FMA347 and 23JBS200. The product was distributed nationwide. A total of 36 units are involved in this recall.
The recall is being conducted due to the use of recalled components in manufacturing these kits. Healthcare facilities and organizations that received these products should contact Medline Industries for instructions regarding the affected items.
The recalled product
- Product
- MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 36
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 DYNJ52141B
- UDI/DI 10195327028459 (each) 40195327028450 (case)
- Lot Numbers: 23FMA347
- 23JBS200
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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