Customed Laparoscopic OB GYN Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 95 packs of laparoscopic OB GYN kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
What this means for you
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 surgical instruments, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Customed, Inc. is recalling 95 packs of laparoscopic OB GYN kits. These 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 ranging from October 31, 2015, to June 30, 2016. The product code is 9001192.
Healthcare facilities and consumers should stop using these products and contact the recalling firm for further instructions or a return. This recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- LAPAROSC. OB GYN PK 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
- Affected units
- 95
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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