Medical Pacemaker Pack Recalled Due to Sterilization Assurance Failure
American Contract Systems is recalling the PACEMAKER PACK (Lot 2405112) due to an inoperable chart recorder that prevented confirmation of sterilization requirements. Affected units were distributed in MO, MN, MA, OH, and NE.
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 medical device with a risk-of-harm situation due to unconfirmed sterilization assurance, which could result in infection risk. No illnesses or injuries have been reported to date. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
American Contract Systems, Inc. is recalling the PACEMAKER PACK, SLCV01J (a medical convenience kit) with Lot number 2405112 and expiration date 05/11/2025.
The recall was initiated because an inoperable chart recorder in one of the manufacturer's controlled environment areas resulted in humidity readings that fell outside acceptable specifications. Because of this equipment failure, American Contract Systems is unable to confirm that the product sterilization assurance requirements were met.
The affected product was distributed nationwide in the states of Missouri, Minnesota, Massachusetts, Ohio, and Nebraska.
Patients and healthcare providers who have received this product should stop using it immediately and contact American Contract Systems for replacement or disposal instructions.
The recalled product
- Product
- PACEMAKER PACK, SLCV01J; Medical convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 20
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 (3)
- UDI-DI: 00191072213846
- Lot: 2405112
- Exp: 05/11/2025
Distribution
Part of a larger recall action
This product is one of 19 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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