Customed Plastic Surgery Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 105 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 the hazard involves potential lack of sterility in medical devices used for surgical procedures, which poses a risk of harm even without reported injuries.
Plain-English summary
Customed, Inc. is recalling 105 units of Plastic Surgery Packs (Code 900920) that were distributed exclusively in Puerto Rico. The affected lots include 141015725 (exp. 10/31/15), 150116826 (exp. 3/31/16), 150317858 (exp. 3/31/16), and 150317859 (exp. 3/31/16). These products are used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, and irrigation.
The recall was initiated because of inadequate validation and qualification of the sterilization processes and package integrity for products released for distribution as sterile. This classification indicates a potential risk that the products may not be sterile as intended.
Medical facilities and consumers who have these specific products should stop using them and contact the recalling firm, Customed, Inc., for instructions on return or disposal.
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
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
- Affected units
- 105
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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