Customed Laparoscopy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 339 packs of Laparoscopy PK 3/CS 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 is classified as FDA Class II. The hazard involves potential sterility failure in a medical device, which poses a risk of harm (infection) even though specific injuries are not reported in the source text.
Plain-English summary
Customed, Inc. is recalling 339 packs of the Laparoscopy PK 3/CS, a medical device used by staff for surgical and patient care procedures. The recall was initiated because of inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released as sterile.
The affected products were distributed only in Puerto Rico. The recall involves specific catalog number 900028 and multiple lot numbers with expiration dates ranging from October 31, 2015, to January 31, 2016.
Healthcare facilities and consumers should stop using these products and contact the manufacturer or the FDA for further instructions on disposal or return.
The recalled product
- Product
- LAPAROSCOPY PK 3/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
- Affected units
- 339
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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