Laparoscopy Pack Recalled for Discoloration from Inadvertent Resterilization
AVID Medical is recalling 452 Laparoscopy Pack units distributed to medical facilities in seven U.S. states due to inadvertent resterilization causing discoloration.
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 no reported injuries or illnesses. Discoloration of surgical equipment from inadvertent resterilization presents a risk-of-harm scenario meeting the threshold for 'High' severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
AVID Medical, Inc. is recalling 452 units of its LAPAROSCOPY PACK medical convenience kit (Models VAML025-05 and WRNM007-15) used in laparoscopic surgical procedures. The recall was initiated because the CLEARIFY VISUALIZATION SYSTEM component was inadvertently resterilized during manufacturing, resulting in discoloration of the affected kits.
The affected units were distributed domestically to medical facilities in California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington. Healthcare providers who received affected kits should contact AVID Medical for replacement or return instructions. Affected lot numbers include 1580078, 1580079, 1580407, 1582536, 1585729, 1596605, 1598248, 1598249, 1607780, 1626103, 1629350, 1639643, and 1627004.
The recalled product
- Product
- LAPAROSCOPY PACK. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Hazard
- discoloration
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 (17)
- Model No. VAML025-05
- WRNM007-15
- UDI: 10809160387696
- 10809160432235
- Kit Lot No. 1580078
- 1580079
- 1580407
- 1582536
- 1585729
- 1596605
- 1598248
- 1598249
- 1607780
- 1626103
- 1629350
- 1639643
- 1627004.
Distribution
Distributed in 7 states:
- CA
- IL
- MD
- OH
- PA
- TX
- WA
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