Customed Open Heart Surgical Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 47 Open Heart Surgical Packs distributed in Puerto Rico 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 surgical pack) where the hazard is theoretical (inadequate sterilization validation) and no injuries or illnesses have been reported in the source text.
Plain-English summary
Customed, Inc. is recalling 47 units of the Open Heart Surgical Pack (Catalog Number 9002618). These sterile medical device packs are used by medical staff to perform surgical procedures and patient care procedures, including wound healing, suture removals, and wound irrigation.
The recall was initiated because of inadequate validation and qualification of the sterilization processes and package integrity for the products released for distribution as sterile. The affected lots were distributed only in Puerto Rico.
The specific lot numbers and dates associated with this recall are SL15177 (30-JUN-16), SL15181 (30-JUN-16), SL15212 (31-JUL-16), SL15215 (31-JUL-16), SL15219 (31-JUL-16), and SL15271 (30-SEP-16). Healthcare facilities and consumers should stop using these products and contact the manufacturer or the FDA for further instructions.
The recalled product
- Product
- Catalog Number: 9002618 OPEN HEART SURGICAL PACK 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
- 47
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 100 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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