Laparoscopy Surgical Packs Recalled Due to Unconfirmed Sterilization
American Contract Systems Inc. is recalling 303 Laparoscopy Packs (Models CALS41F, CALS41F-01, CALS41G) because sterilization assurance requirements could not be confirmed. Unsterilized instruments may cause infection or delayed treatment.
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: This is an FDA Class II recall of surgical instruments where sterilization assurance could not be confirmed. Although no illnesses or injuries have been reported, unsterilized surgical instruments pose a risk of infection and surgical complications, meeting the criteria for a risk-of-harm product.
Plain-English summary
American Contract Systems Inc. is recalling 303 Laparoscopy Packs (Models CALS41F, CALS41F-01, CALS41G). The recall was initiated because the manufacturer could not confirm that sterilization assurance requirements were met during manufacturing.
Laparoscopy packs are surgical instrument kits used in minimally invasive surgical procedures. If instruments are not properly sterilized, they pose a risk of infection and other complications, which may result in delayed or prolonged treatment.
Healthcare facilities should verify their inventory against the affected lot numbers and follow FDA recall guidance. The affected lots are: Model CALS41F (Tray Lots 962241, 70-050280, 70-050870, 70-051556), Model CALS41F-01 (Tray Lot 70-052412), and Model CALS41G (Tray Lot 70-053051).
The recalled product
- Product
- LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
- Manufacturer
- American Contract Systems Inc
- Affected units
- 303
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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