Customed Angiodrape PK 4/CS Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 192 packs of Angiodrape PK 4/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 and involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Customed, Inc. is recalling 192 packs of Angiodrape PK 4/CS, a medical device used by staff for surgical procedures and patient care 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 for distribution as sterile.
The affected products are distributed only in Puerto Rico. The recall includes specific lots with catalog number 900002 and expiration dates ranging from January 31, 2016, to July 30, 2017.
Consumers and healthcare facilities should stop using the affected products and contact the recalling firm for further instructions.
The recalled product
- Product
- ANGIODRAPE PK 4/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
- 192
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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