Customed Recalls Lap-Cholecystectomy Surgical Packs Due to Sterilization Issues
Customed, Inc. is recalling 320 lap-cholecystectomy surgical packs distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text identifies the agency classification as Class II. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated as Severe (4). While no specific injuries are reported in the text, the failure of sterilization validation for surgical packs represents a significant risk of infection, aligning with the Severe criteria for Class II medical device recalls.
Plain-English summary
Customed, Inc. is recalling 320 units of the Lap-Cholecystectomy Surgical Pack. These products are used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, and wound irrigation. 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.
The affected products were distributed only in Puerto Rico. The recall involves specific lots with code 900576A, including lot numbers 140915210, 140915495, 141216351, 141216447, 150116947, 150518827, 150518911, 150519007, and 150619186. The expiration dates for these lots range from May 31, 2015, to June 30, 2016.
Healthcare facilities and consumers should stop using these specific surgical packs and contact Customed, Inc. for further instructions or a return. The FDA has classified this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- LAP-CHOLECYSTECTOMY 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
- 320
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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