Customed Laparoscopic Gynecology Surgical Packs Recalled for Sterilization Issues
Customed, Inc. is recalling 30 units of Laparoscopic Gynecology Surgical Packs due to inadequate sterilization validation and package integrity concerns.
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 due to inadequate sterilization validation, and no injuries or illnesses have been reported in the source text.
Plain-English summary
Customed, Inc. is recalling 30 units of Catalog Number 900484 Laparoscopic Gynecology Surgical Packs. These products 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 SL15203 (150719885) with a date of 31-JUL-16 and SL15271 (150920829) with a date of 30-SEP-16.
The products were distributed only in Puerto Rico. Medical facilities and consumers who have these specific lots should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Catalog Number: 900484 LAPAROSCOPIC GYNECOLOGY 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
- 30
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: SL15203 (150719885) 31-JUL-16 SL15271 (150920829) 30-SEP-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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