Labor and Delivery Pack Recalled Over Unconfirmed Sterilization
American Contract Systems is recalling 725 Labor & Delivery Packs because the manufacturer cannot confirm sterilization requirements were met. Devices may lack functionality and could delay or prolong patient 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 for a medical device used in critical obstetric care. While no illnesses or injuries have been reported, the potential for sterilization failure and resulting loss of device functionality qualifies as a risk-of-harm product where injury has not yet been reported, placing it at Score 3.
Plain-English summary
American Contract Systems Inc. is recalling 725 LABOR & DELIVERY PACK units (Model LLLD19H) due to unconfirmed sterilization assurance. The manufacturer is unable to confirm that sterilization requirements were met during manufacturing.
Medical devices used in labor and delivery must meet strict sterilization standards to function properly and safely. If proper sterilization was not achieved, the devices may experience loss or lack of functionality, which could result in delayed or prolonged patient treatment during critical medical care.
The affected kits were distributed nationwide, with particular distribution in Ohio. Affected lots are identified by numbers 885241, 70-051324, 70-051967, 70-052455, and 70-053006. Healthcare facilities currently using these kits should immediately discontinue use of affected lots and contact American Contract Systems Inc. for replacement or disposal instructions.
The recalled product
- Product
- LABOR & DELIVERY PACK, Model Nos LLLD19H
- Manufacturer
- American Contract Systems Inc
- Affected units
- 725
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI 00191072219213 Lots 885241 70-051324 70-051967 70-052455 70-053006
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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