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.
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 3/5 (High).
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
- 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.
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