Customed PERI GYN PACK recalled for sterilization validation issues
Customed, Inc. is recalling 115 units of PERI GYN PACK 5/CS 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 involves a risk-of-harm product (sterile medical device) where the hazard is theoretical due to inadequate sterilization validation, and no injuries or illnesses have been reported.
Plain-English summary
Customed, Inc. is recalling 115 units of PERI GYN PACK 5/CS. These sterile medical packs are used by medical staff for surgical procedures and patient care, including 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.
The affected products were distributed only in Puerto Rico. The specific lot numbers and expiration dates are: 141015748 (exp. 10/31/15), 150116983 (exp. 1/31/16), 150518852 (exp. 5/31/16), 150317855 (exp. 5/31/16), and 150619300 (exp. 6/30/16). The product code is 900997.
Medical facilities and consumers should stop using these products and contact the recalling firm for further instructions.
The recalled product
- Product
- PERI GYN 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
- 115
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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