Customed Breast Pack Recall Due to Sterilization Validation Issues
Customed, Inc. is recalling 33 units of Breast Pack-TPSC in Puerto Rico 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 risk-of-harm product (sterile medical device) where the defect (inadequate sterilization) presents a theoretical risk of infection, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Customed, Inc. is recalling 33 units of the Breast Pack-TPSC (Lot 141015600, exp. 10/31/15). These medical packs are used by staff for surgical procedures and patient care, including wound healing and suture removals. The recall is limited to products distributed in Puerto Rico.
The recall was initiated because of inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released as sterile. This defect raises the risk that the products may not be sterile when used.
Healthcare facilities and consumers who have these specific units should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- BREAST PACK-TPSC 3/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
- 33
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:9003431 Lot: 141015600 exp. 10/31/15
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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