GS endoscopy packs contain an inadvertently resterilized visualization system
GS Endoscopy Pack medical convenience kits are being recalled because the Clearify Visualization System inside was inadvertently resterilized, causing discoloration. 816 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 recall over discoloration from an unintended resterilization, with no device defect or clinical consequence stated in the source.
Plain-English summary
The GS Endoscopy Pack medical convenience kit, model numbers NAMC421-10, NAMC421-11 and NAMC421-12, is being recalled. The action covers 816 units, identified by the UDI codes and kit lot numbers in the recall notice.
The stated reason is that the Clearify Visualization System was inadvertently resterilized in the kits, causing discoloration. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Distribution was domestic, to California, Illinois, Maryland, Ohio, Pennsylvania, Texas and Washington. The kits are supplied to surgical facilities rather than sold to consumers.
Facilities should identify affected stock using the model numbers, UDI codes and kit lot numbers and follow the instructions issued by the manufacturer.
The recalled product
- Product
- GS ENDOSCOPY PACK. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 816
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. NAMC421-10
- NAMC421-11
- NAMC421-12
- UDI: 10809160374597
- 10809160417539
- 10809160435779
- Kit Lot No. 1584375
- 1588403
- 1605341
- 1615427
- 1615428
- 1627706
- 1628153
- 1628008
- 1628009
- 1628647
- 1632992.
Distribution
Part of a larger recall action
This product is one of 24 recalled by AVID Medical, Inc. 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.
See all 24 products in this recall →Related recalls
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