Customed Laparotomy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 76 laparotomy surgical 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 involves a risk-of-harm product (sterile surgical pack) where injury has not yet been reported, which aligns with the High severity criteria for theoretical hazards without reported illness.
Plain-English summary
Customed, Inc. is recalling 76 units of Catalog Number 9002516 Laparotomy Surgical Packs. These sterile products 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 sterilization processes, as well as package integrity issues for products released for distribution as sterile.
The affected products were distributed only in Puerto Rico. The recall involves specific lots with expiration dates of July 31, 2016, and August 31, 2016. The lot codes are SL15203 (150719261), SL15203 (150719842), SL15211 (150719261), SL15211 (150719842), SL15244 (150820297), and SL15245 (150820297).
The source text does not specify instructions for consumers or healthcare facilities regarding the disposal or return of these products. No illnesses or injuries are reported in the source text.
The recalled product
- Product
- Catalog Number: 9002516 LAPAROTOMY 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
- 76
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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