Customed Cysto TUR Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 72 Cysto TUR 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 is classified as FDA Class II and 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.
Plain-English summary
Customed, Inc. is recalling 72 units of the Cysto TUR Surgical Pack (Catalog Number 9002899). 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 recall was initiated because of inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released for distribution as sterile. The affected lots are SL15174 (150518912) and SL15240 (150820312). The products were distributed only in Puerto Rico.
This recall is classified as Class II by the FDA. Medical facilities and consumers who have these specific surgical packs should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Catalog Number: 9002899 CYSTO TUR 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
- 72
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)
- LOTS: SL15174 (150518912) 30-JUN-16 SL15240 (150820312) 31-AUG-16
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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