Customed Breast Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 24 units of Breast Packs 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Customed, Inc. is recalling 24 units of Breast Packs (Code 9003029, Lot 141015592, expiration 5/31/17). These products 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 sterilization processes, as well as package integrity issues for products released as sterile. The affected units were distributed only in Puerto Rico.
Medical facilities and consumers should stop using these specific units and contact the recalling firm for further instructions.
The recalled product
- Product
- BREAST PACK-BOD 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
- 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:9003029 Lot: 141015592 exp. 5/31/17
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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