The Recall Desk
HighFDA (Devices)·Z-2709-2015·Announced 2015-09-09

Customed Arthroscopy Packs Recalled for Sterilization Validation Issues

Customed, Inc. is recalling Arthroscopy Packs due to inadequate validation of sterilization processes and package integrity for products released as sterile.

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: The recall is classified as FDA Class II. The hazard involves potential sterility failure in surgical products, which poses a risk of harm (infection) even though no specific injuries are reported in the source text.

Plain-English summary

Customed, Inc. is recalling Arthroscopy Packs (Code 900902) because of inadequate validation and qualification of sterilization processes and package integrity. The affected products were released for distribution as sterile.

The recall involves specific lots: 141015741 (exp. 10/31/15) and 150518846 (exp. 5/31/16). These products were distributed only in Puerto Rico.

Medical staff should stop using the affected Arthroscopy Packs and contact the recalling firm for further instructions.

The recalled product

Product
ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Manufacturer
Customed, Inc
Category
Medical Device — Surgical Packs
Hazard
Affected units
3

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 170 recalled by Customed, 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 170 products in this recall →

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Same hazard · sterility failure

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