Customed Umbilical Vessel Catheter Kits Recalled for Sterilization Defects
Customed, Inc. is recalling 48 umbilical vessel catheter kits 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 defect in sterilization validation, which poses a risk of harm (infection) even though no specific injuries are reported in the source text.
Plain-English summary
Customed, Inc. is recalling 48 units of the Umbilical Vessel Catheter Kit (Code: 9001408). The affected lots are 141015796 (expiration 4/30/15) and 140814647 (expiration 6/30/16). These kits are used by medical staff for surgical procedures and patient care, including wound healing and suture removals.
The recall was initiated because of inadequate validation and qualification of the sterilization processes and package integrity for products released for distribution as sterile. This defect raises the risk that the devices may not be sterile when used.
The affected products were distributed only in Puerto Rico. Medical facilities and consumers who have these specific kits should stop using them and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- UMBILICAL VESSEL CATHETER KIT CUSTOMED 8/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
- 48
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Code:9001408 Lots: 141015796 exp. 4/30/15 140814647 exp. 6/30/16
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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