Customed Laparoscopy OB 6/CS Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 36 units of Laparoscopy OB 6/CS devices 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 failure of sterilization for a surgical instrument, which poses a risk of harm (infection) even though no specific illnesses or injuries are reported in the source text.
Plain-English summary
Customed, Inc. is recalling 36 units of the Laparoscopy OB 6/CS medical device. These instruments are used by medical staff to perform surgical procedures and patient care tasks, including wound healing, suture removals, and wound irrigation. The recall was initiated because of inadequate validation and qualification of the sterilization processes, as well as issues with package integrity for products released for distribution as sterile.
The affected units were distributed only in Puerto Rico. The specific lot numbers involved are 141015745 (exp. 11/30/15), 150116812 (exp. 3/31/16), 150317993 (exp. 4/30/16), and 150317992 (exp. 4/30/16). The product code is 900484.
Healthcare facilities and consumers should stop using these specific devices and contact Customed, Inc. for instructions on how to return or dispose of the recalled items.
The recalled product
- Product
- LAPAROSCOPY OB 6/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
- 36
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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