Customed Central Line Full Body Drapes Recalled for Sterilization Issues
Customed, Inc. is recalling 56 units of Central Line Full Body Drapes 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 involves a medical device with a risk of harm (inadequate sterilization) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Customed, Inc. is recalling 56 units of Central Line Full Body Drapes (Code 9002262). 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 lots are 150217392 (exp. 3/31/16), 150116999 (exp. 2/28/16), 150518693 (exp. 6/30/16), and 150619400 (exp. 6/30/16). These products were distributed only in Puerto Rico and are used by medical staff for surgical procedures and patient care, such as wound healing and suture removals.
Medical facilities and consumers should stop using these specific lots and contact the recalling firm or the FDA for further instructions.
The recalled product
- Product
- CENTRAL LINE FULL BODY DRAPE CUSTOMED 28/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
- Category
- Medical Device — Surgical Drapes
- Affected units
- 56
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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