Customed Laparoscopy-Gyn Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 36 units of Laparoscopy-Gyn Surgical Packs 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 agency classification is Class II, and the hazard involves inadequate sterilization validation for surgical products, which poses a significant risk of infection or injury, meeting the criteria for a Severe rating.
Plain-English summary
Customed, Inc. is recalling 36 units of Catalog Number 900618A Laparoscopy-Gyn Surgical Packs. These products are used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall was initiated because of inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released for distribution as sterile. The affected lots are SL15197 (150719808), SL15240 (150820341), and SL15271 (150920991).
The products were distributed only in Puerto Rico. Medical facilities and consumers should stop using these products and contact the recalling firm for further instructions.
The recalled product
- Product
- Catalog Number: 900618A LAPAROSCOPY-GYN SURGICAL PACK 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
- 36
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 100 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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