The Recall Desk
ModerateFDA (Devices)·Z-0800-2018·Announced 2018-03-07

Avid Medical Recalls Shoulder Arthroscopy Kits with Foreign Material

Avid Medical is recalling 24 shoulder arthroscopy kits because they may contain loose polypropylene foreign material in the needles.

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: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Avid Medical, Inc. is recalling 24 AVID TruCustom SHOULDER ARTHROSCOPY convenience kits, Item Code: MADN010-02. The recall involves specific lots with expiration dates of 9/1/2018, 12/31/2018, and 12/1/2018.

The kits are being recalled because they may contain BD 22GA 1-1/2 inch SafetyGlide Non Sterile Bulk needles that have loose polypropylene foreign material above the release specification. The affected products were distributed in 10 states: Illinois, Kentucky, Louisiana, Massachusetts, Missouri, New York, Ohio, Texas, Virginia, and Wisconsin.

Healthcare providers and consumers should stop using these specific kits and contact Avid Medical, Inc. for instructions on return or replacement.

The recalled product

Product
AVID TruCustom SHOULDER ARTHROSCOPY convenience kits, Item Code: MADN010-02
Manufacturer
Avid Medical, Inc.
Affected units
24

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)

  • Lot
  • Expiration Date: 1203383
  • 9/1/2018
  • 1217833
  • 12/31/2018
  • 1218421
  • 12/1/2018

Distribution

Distributed in 10 states:

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.

See all 23 products in this recall →