Customed Tummy Tuck and Breast Packs Recalled for Sterilization Issues
Customed, Inc. is recalling 24 Tummy Tuck & Breast Packs distributed in Puerto Rico due to inadequate sterilization validation 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. The hazard involves a risk of harm (infection) from non-sterile medical devices, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Customed, Inc. is recalling 24 units of the Tummy Tuck & Breast Pack-RFMHI (6/CS). 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 specific lot number is 141015586, with an expiration date of 11/30/15.
The recall was initiated because of inadequate validation and qualification of the sterilization processes, as well as issues with package integrity for products that were released for distribution as sterile. This means the devices may not be sterile as intended.
The affected products were distributed only in Puerto Rico. Consumers and medical facilities should stop using these products and contact the recalling firm for further instructions.
The recalled product
- Product
- TUMMY TUCK & BREAST PACK-RFMHI 6/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 Packs
- Affected units
- 24
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:9002662 Lots: 141015586 exp. 11/30/15
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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