Laparoscopy Packs Recalled Due to Unconfirmed Sterilization Assurance
American Contract Systems Inc is recalling 630 laparoscopy pack kits due to unconfirmed sterilization assurance. This could cause 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 recall with no reported hospitalizations or injuries. It qualifies as a risk-of-harm medical device where injury has not yet been reported, justifying a High classification per the rubric.
Plain-English summary
American Contract Systems Inc is recalling LAPAROSCOPY PACK Model Nos LLLA21J and LLLA21J-02. The recall involves 630 kits distributed nationwide in Ohio, identified by UDI-DI 00191072219206 and specific lot numbers (882241, 70-051163, 70-051373, 70-051564, 70-052582, 70-053048).
The company is unable to confirm that sterilization assurance requirements were met during manufacturing. Without proper sterilization, these packs may not function as intended and could lead to delayed or prolonged treatment for patients.
The FDA has classified this as a Class II recall. Healthcare facilities and practitioners who received these kits should contact American Contract Systems Inc for guidance regarding next steps.
The recalled product
- Product
- LAPAROSCOPY PACK, Model Nos LLLA21J LLLA21J-02
- Manufacturer
- American Contract Systems Inc
- Affected units
- 630
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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