Customed Shoulder Pack Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 6 units of Shoulder Packs due to inadequate validation of sterilization processes and package integrity.
What this means for you
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 hazard is theoretical (potential lack of sterility) and no injuries or illnesses have been reported in the source text.
Plain-English summary
Customed, Inc. is recalling 6 units of Shoulder Packs (Code 9001985) that were distributed in Puerto Rico. The affected lots are 150116783 (exp. 1/31/16) and 150317639 (exp. 5/31/16). These medical devices are used by staff to perform surgical and patient care procedures, 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. This classification indicates a potential risk that the devices may not be sterile as intended.
Healthcare facilities and consumers who have these specific lots should stop using the products and contact the manufacturer or their supplier for instructions on return or replacement.
The recalled product
- Product
- SHOULDER PACK CUSTOMED 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
- Affected units
- 6
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:9001985 Lots: 150116783 exp. 1/31/16 150317639 exp. 5/31/16
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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