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U.S. Department of Health and Human Services

Class 2 Device Recall American Contract Systems

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 Class 2 Device Recall American Contract Systemssee related information
Date Initiated by FirmSeptember 04, 2025
Date PostedOctober 16, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0183-2026
Recall Event ID 97659
Product Classification Neurological tray - Product Code OJG
ProductMedical convenience kits Item Number/Description HSLM53AB SPINE PACK MILM82A DTC LAMINECTOMY PACK (PS 209475) RCNA47B NEURO ANGIO 0246971 SFLM54AB LAMINECTOMY PACK - 219659 UDLM94AA LAMINECTOMY PACK - 206064 UILM77AU LAMINECTOMY (PS 039500) UINR44P NEURO IR PERIPHERAL (PS 64405) UISH15AV SHUNT PACK (PS 039360)
Code Information ANLM40AG UDI-DI 191072232076 Lot 8192111 Bag serial number 68195596; ANPP15AR UDI-DI 191072214423 Lot 8024911 Bag serial number 68055493; HSLM53AB UDI-DI 191072224095 Lot 8061111 Bag serial number 68138767; MILM82A UDI-DI 191072231512 Lot 8361111 Bag serial number 68576542; RCNA47B UDI-DI 191072228536 Lot 8441711 Bag serial number 68680026; SFLM54AB UDI-DI 191072217400 lot 8105511 Bag serial number N/A; UDLM94AA UDI-DI 191072214089 Lot 8382011 Bag serial number 17621919; UILM77AU UDI-DI 191072210333 Lot 8056311 Bag serial number N/A; UINR44P UDI-DI 191072210340 Lot 8067511 Bag serial numbers 68138618 68140374; UISH15AV UDI-DI 191072227843 Lot 8028211 Bag serial number 68154067 * If bag serial number is listed as "N/A", then whole lot is affected
Recalling Firm/
Manufacturer		 American Contract Systems Inc.
1601 Se Gateway Dr Ste 120
Grimes IA 50111-5223
For Additional Information ContactMarlene Jones
470-280-4277
Manufacturer Reason
for Recall		Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionFirm notified affected distributors who received affected product via email on 9/4/25. An updated letter was provided on 9/9/25, which better clarified product codes and impacted lot numbers and bag serial numbers. Consignees were instructed to immediately discontinue use and discard impacted trays. Distribution partners were provided with a customer letter for further distribution to end users.
Quantity in Commerce32,433 total
DistributionUS Nationwide distribution in the states of SD, IA, MN, WA, IL.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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