Customed Cystoscopy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 140 Cystoscopy Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 packs) where inadequate sterilization validation poses a theoretical risk of infection, but the source text does not report any actual illnesses or injuries.
Plain-English summary
Customed, Inc. is recalling 140 units of Cystoscopy Surgical Packs, Catalog Number 900080. 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 products were distributed only in Puerto Rico. The recall covers specific lots with the following identifiers: SL15187 (150619473) dated 30-JUN-16, SL15197 (150719616) dated 31-JUL-16, SL15240 (150820571) dated 31-AUG-16, SL15251 (150920666) dated 30-SEP-16, and two lots of SL15259 (150920926 and 150920925) dated 30-SEP-16.
Medical facilities and consumers should stop using these products and contact the recalling firm for instructions on return or disposal. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Catalog Number: 900080 CYSTOSCOPY 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
- 140
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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