Customed Obstetrical Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 304 Obstetrical Surgical Packs 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 the hazard involves potential sterility failure in surgical packs, which poses a risk of harm (infection) even though no specific injuries are reported in the source text.
Plain-English summary
Customed, Inc. is recalling 304 units of Obstetrical Surgical Packs (Catalog Number 9002940) distributed in Puerto Rico. 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 include SL15197, SL15208, SL15216, SL15225, SL15230, SL15243, SL15272, and SL15273, with expiration dates ranging from July 31, 2016, to September 30, 2016.
Medical facilities and consumers who have these specific products should stop using them and contact Customed, Inc. for further instructions or a return.
The recalled product
- Product
- Catalog Number: 9002940 OBSTETRICAL 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
- 304
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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