Customed Arthroscopy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 45 Arthroscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in the sterilization process of a sterile medical device, which poses a significant risk of infection or injury, meeting the criteria for a Severe rating.
Plain-English summary
Customed, Inc. is recalling 45 Arthroscopy Packs (Code 9001042) that were distributed exclusively in Puerto Rico. The recall was initiated because of inadequate validation and qualification of the sterilization processes, as well as concerns regarding package integrity for products released for distribution as sterile.
The affected lots include 141015735 (exp. 10/31/15), 141115970 (exp. 11/30/15), 150116726 (exp. 1/31/16), and 150116967 (exp. 2/28/16). These packs are used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, and wound irrigation.
The U.S. Food and Drug Administration has classified this recall as Class II. Medical facilities and consumers in Puerto Rico who possess these specific lots should stop using the products and contact the recalling firm for instructions on return or replacement.
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
- 45
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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