Customed O.B. Pack Hospital 3/CS Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 147 units of O.B. Pack Hospital 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving critical attributes like sterilization validation for surgical products.
Plain-English summary
Customed, Inc. is recalling 147 units of O.B. Pack Hospital 3/CS, a medical product used by staff for surgical and patient care procedures such as wound healing and suture removals. 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 specific lot numbers involved are 141015504, 150116817, 150217475, 150217476, 150217477, and 150217478, with expiration dates ranging from November 30, 2015, to March 31, 2016.
This recall is classified as Class II by the FDA. Medical facilities should stop using the affected products and contact the manufacturer for further instructions.
The recalled product
- Product
- O.B. PACK HOSPITAL 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
- 147
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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