GYN Laparoscopy Packs Recalled for Discoloration from Resterilization
AVID Medical is recalling 346 GYN Laparoscopy Packs due to discoloration caused by inadvertent resterilization. Affected kits were distributed in seven states.
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: FDA Class II medical device recall with a documented manufacturing defect (discoloration). No illnesses or injuries are reported in the source, and the recall is precautionary in nature.
Plain-English summary
AVID Medical, Inc. is recalling 346 GYN Laparoscopy Packs (medical convenience kits used in gynecological laparoscopic surgical procedures) because the Clearify Visualization System component was inadvertently resterilized, causing discoloration.
The affected kits were distributed domestically in California, Illinois, Maryland, Ohio, Pennsylvania, Texas, and Washington. The kits are identified by model numbers NAFB055-08, NAMC436-11, and VMCC030-06, with affected lot numbers including 1595523, 1598524, 1598523, 1628236, 1634348, 1636865, 1645025, 1645227, and others listed in the FDA recall notice.
Healthcare facilities and surgical centers that received these kits should contact AVID Medical, Inc. for instructions on device replacement or return. Complete recall details and instructions are available in the FDA recall notice.
The recalled product
- Product
- GYN LAPAROSCOPY PACK. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Hazard
- discoloration
- product-defect
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 (20)
- Model No. NAFB055-08
- NAMC436-11
- VMCC030-06
- UDI: 10809160405185
- 10809160417621
- 10809160415245
- 10809160419021
- Kit Lot No. 1595523
- 1598524
- 1598523
- 1628236
- 1634348
- 1636865
- 1645025
- 1645227
- 1608234
- 1608349
- 1608466
- 1613607
- 1613139
Distribution
Distributed in 7 states:
- CA
- IL
- MD
- OH
- PA
- TX
- WA
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