Laparoscopy Surgical Packs Recalled Due to Unconfirmed Sterilization
American Contract Systems Inc is recalling 237 laparoscopy surgical packs because sterilization assurance could not be confirmed. The packs may experience loss of functionality and require treatment delays.
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: FDA Class II medical device where sterilization assurance could not be confirmed. No hospitalizations or injuries reported, but potentially non-sterile surgical instruments pose significant risk of patient harm, placing this in the risk-of-harm category.
Plain-English summary
American Contract Systems Inc is recalling 237 laparoscopy surgical packs (Models SFLA02A and SFLA02B) distributed nationwide in Ohio. The company was unable to confirm that sterilization assurance requirements were met.
The affected surgical packs may experience loss or lack of functionality, which could lead to delays or prolonged treatment during laparoscopy procedures.
Healthcare facilities should immediately stop using affected lot numbers (971241, 947241, 926241, 894241, 70-051029, 70-051995, 70-052417, 70-052771) and contact American Contract Systems Inc for replacement or refund instructions. Patients who have undergone or are scheduled for procedures should consult their healthcare provider with any concerns.
The recalled product
- Product
- LAPAROSCOPY PACK , Model No SFLA02A SFLA02B
- Manufacturer
- American Contract Systems Inc
- Hazard
- sterilization-failure
- device-malfunction
Distribution
Distributed nationwide across the United States.
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