Customed Plastic Surgery Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 55 plastic surgery 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 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 and involves a risk-of-harm product (sterile medical device) where the hazard is theoretical due to inadequate sterilization validation, with no reported injuries or illnesses in the source text.
Plain-English summary
Customed, Inc. is recalling 55 units of the Plastic Surgery Pack 5/CS. These sterile medical packs are used by medical staff to perform surgical procedures and patient care procedures, including wound healing, suture removals, and wound irrigation.
The recall was initiated because of inadequate validation and qualification of the sterilization processes, as well as package integrity issues for products released for distribution as sterile. The affected lots are 141015795 (exp. 10/31/15), 141115978 (exp. 11/30/15), 150418495 (exp. 4/30/16), and 150619485 (exp. 6/30/16), all under code 9001402.
The products were distributed only in Puerto Rico. Medical facilities and consumers should stop using these specific lots and contact the recalling firm for further instructions.
The recalled product
- Product
- PLASTIC SURGERY PACK 5/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
- 55
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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