Aesculap Sterile Disposable Fleece Drape Recalled Due to Packaging Seal Integrity Issue
Aesculap recalls 4500 sterile disposable fleece drapes (Product code GA414) due to unvalidated packaging seal integrity, which may compromise sterility assurance. Distribution occurred in 14 U.S. states.
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 a Class II FDA medical device recall involving loss of sterility assurance on surgical drapes. The product is a risk-of-harm item where sterility is critical in surgical settings, and no illnesses or injuries have been reported, matching the rubric criterion for High severity.
Plain-English summary
Aesculap Implant Systems LLC is recalling 4500 Aesculap Sterile disposable fleece drapes (Product code GA414, SZ380R) distributed to medical facilities in 14 U.S. states: California, Colorado, Georgia, Illinois, Indiana, Kentucky, Michigan, North Carolina, Nebraska, New York, Ohio, Rhode Island, Virginia, and Wisconsin.
The drapes were recalled because the packaging seal integrity was not properly validated, which results in a lack of sterility assurance. A sterile drape with compromised packaging may no longer maintain its sterility, creating a risk if used in surgical or medical procedures.
Affected lot numbers are 551953371, 52024524, 52097698, 52172460, 52249972, and 52340448 (UDI-DI/GTIN: 04038653067862). No illnesses or injuries have been reported.
Healthcare facilities and medical professionals in the affected states should stop using the recalled drapes and contact Aesculap Implant Systems LLC for instructions on return or replacement.
The recalled product
- Product
- Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
- Manufacturer
- Aesculap Implant Systems LLC
- Category
- Medical Device — Surgical Drapes
- Affected units
- 4,500
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)
- UDI-DI (GTIN): 04038653067862
- lots 551953371
- 52024524
- 52097698
- 52172460
- 52249972
- and 52340448.
Distribution
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