Customed Recalls Peri Gyn Packs Due to Sterilization Validation Issues
Customed, Inc. is recalling 130 units of Peri Gyn Packs in Puerto Rico because sterilization processes and package integrity were not adequately validated.
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 validation, with no reported illnesses or injuries in the source text.
Plain-English summary
Customed, Inc. is recalling 130 units of Peri Gyn Packs, which are used by medical staff for surgical procedures and patient care such as wound healing and suture removals. The recall was initiated because the sterilization processes and package integrity for these products were not adequately validated or qualified before they were released for distribution as sterile.
The affected products were distributed only in Puerto Rico. The specific lots involved are 141015503 (exp. 11/30/15), 150116816 (exp. 2/28/16), 150116995 (exp. 2/28/16), 150318014 (exp. 4/30/16), and 150318015 (exp. 4/30/16), all under code 900635.
Medical facilities and consumers in Puerto Rico should stop using these specific lots and contact Customed, Inc. for further instructions or a return.
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 wounds, etc. .
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
- Affected units
- 130
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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