General Laparoscopic Pack Recall Due to Unconfirmed Sterilization
American Contract Systems Inc is recalling 534 kits of General Laparoscopic Pack-LF surgical instruments because sterilization assurance could not be confirmed. This could result in loss of functionality and 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: This is a Class II medical device recall involving unconfirmed sterilization of surgical instruments. Although no illnesses or injuries have been reported, the failure to confirm sterilization assurance on surgical instruments represents a significant risk of harm, meeting the criterion for High (3) severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
American Contract Systems Inc is recalling 534 kits of General Laparoscopic Pack-LF surgical instruments (models UTGL53S-06, UTGL53S-07, and UTGL53S-08). The recall affects units distributed nationwide in Ohio.
The manufacturer is unable to confirm that product sterilization assurance requirements were met. According to the recall notice, possible loss or lack of functionality may lead to delay or prolonged treatment.
The recall includes lot numbers 941241, 899241, 70-050873, 70-051230, 70-051578, 70-052009A, and 70-052884. Healthcare facilities should check their inventory against these lot numbers and quarantine affected units pending further guidance from the manufacturer.
The recalled product
- Product
- GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
- Manufacturer
- American Contract Systems Inc
- Affected units
- 534
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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