Customed Recalls Umbilical Vessel Catheter Kits Due to Sterilization Concerns
Customed, Inc. is recalling 40 umbilical vessel catheter kits distributed in Puerto Rico because of 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 due to inadequate sterilization validation, but the source text does not report any illnesses or injuries, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Customed, Inc. is recalling 40 units of the Umbilical Vessel Catheter Kit, Catalog Number 9001408. These medical devices 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 lots are SL15169 (140814647) with a date of 30-JUN-16, SL15202 (150719858) with a date of 31-JUL-16, and SL15225 (150820446) with a date of 31-AUG-16. The products were distributed only in Puerto Rico.
The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled items, nor does it report any illnesses or injuries associated with the use of these devices.
The recalled product
- Product
- Catalog Number: 9001408 UMBILICAL VESSEL CATHETER KIT 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
- 40
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 100 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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