Customed Laparotomy Pack Recall Due to Sterilization Validation Issues
Customed, Inc. is recalling 243 units of Laparotomy Packs distributed in Puerto Rico because of 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 a risk-of-harm product (sterile medical device) where the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria.
Plain-English summary
Customed, Inc. is recalling 243 units of Laparotomy Packs (Code 900996) that were distributed exclusively in Puerto Rico. The affected lots include 141015747, 150116833, 150317665, 150318129, and 150518851, with expiration dates ranging from November 30, 2015, to May 31, 2016. These medical devices are used by medical staff for surgical procedures and patient care, including wound healing and suture removals.
The recall was initiated due to inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released for distribution as sterile. This classification indicates a potential risk that the devices may not be sterile as intended.
Healthcare facilities and consumers in Puerto Rico who possess these specific lots should stop using the products and contact Customed, Inc. for further instructions or a return.
The recalled product
- Product
- LAPAROTOMY PACK 3/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
- 243
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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