Avid Medical Recalls GYN Laparoscopy Kits With Foreign Material
Avid Medical is recalling 160 GYN laparoscopy kits because they may contain needles with loose polypropylene foreign material.
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: The recall is classified as FDA Class II, which typically corresponds to a moderate severity level where the hazard is unlikely to cause serious adverse health consequences but may cause temporary or medically reversible harm.
Plain-English summary
Avid Medical, Inc. is recalling 160 AVID TruCustom GYN LAPAROSCOPY convenience kits (Item Codes LGHM013-06 and LGHM013-07). The affected lots are 1191787 (expiration 7/1/2018) and 1216674 (expiration 9/1/2019). The kits were distributed in Illinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia, and Wisconsin.
The recall was initiated because certain kits contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that may contain loose polypropylene foreign material above the release specification. This foreign material is a quality control deviation that does not meet the manufacturer's established standards.
Healthcare facilities and consumers who have these specific kits should stop using them and contact Avid Medical, Inc. for instructions on return or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- AVID TruCustom GYN LAPAROSCOPY convenience kits, Item Code: LGHM013-06 and LGHM013-07
- Manufacturer
- Avid Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 160
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 (5)
- Lot
- Expiration Date: 1191787
- 7/1/2018
- 1216674
- 9/1/2019
Distribution
Part of a larger recall action
This product is one of 23 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.
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