Medline Sterile Laparoscopy Pack Recalled for Component Defect
Medline recalls Sterile Laparoscopy Packs due to a manufacturing defect in the Detachable Endo Pocket component. The tube may stretch from the pouch during surgical procedures, potentially affecting tissue collection.
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: FDA Class II medical device recall with a manufacturing defect in the device component. No illnesses or injuries have been reported. The hazard poses potential device malfunction during surgical use, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling Sterile Laparoscopy Packs (DYNJ68187A) that contain the ConMed/Unimax Detachable Endo Pocket component. The Detachable Endo Pocket is used to collect and extract tissues, organs, and calculi during general and laparoscopic surgical procedures.
The tube inside the pouch may stretch out from the pouch opening if it is not precisely fixed during manufacturing. This defect could affect the proper function of the device during use.
Affected lot numbers are 24AMA209 (expiration 06/30/2025), 24BMB025 (expiration 08/31/2025), and 23LMA745 (expiration 07/31/2025). Healthcare facilities and providers should verify their inventory against these lot numbers.
The recalled product
- Product
- Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 72
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 (8)
- Lot numbers 24AMA209
- exp. 2025-06-30
- 24BMB025
- exp. 2025-08-31
- 23LMA745
- exp. 2025-07-31
- UDI-DI each 10195327384494
- UDI-DI case-40195327384495
Distribution
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