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.
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: 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
- Affected units
- 237
Distribution
Part of a larger recall action
This product is one of 32 recalled by American Contract Systems 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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