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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-0174-2026
Recall Event ID 97659
Product Classification Endoscope introducer kit - Product Code NWU
ProductMedical convenience kits Item Number/Description BUCY78E CYSTO PACK CMCP10X CYSTO PACK - 205972 IHCY10Y CYSTO PACK MHCY35AE CYSTO PACK- 212487 PLBY52E CYSTO PACK UDCY31Z CYSTO PACK - 206047 UICY28L MOR CYSTO PACK
Code Information BUCY78E UDI-DI 191072235350 Lot 8531411 Bag serial number 17705421; CMCP10X UDI-DI 191072228215 Lot 8392411 Bag serial number 17622370; IHCY10Y UDI-DI 191072159922 Lot 8026111 Bag serial number 17499185 Lot 8346211 Bag serial number 17692649 Lot 8444211 Bag serial number 17681124; MHCY35AE UDI-DI 191072228864 Lot 7990511 Bag serial number N/A; PLBY52E UDI-DI 191072141415 Lot 8016811 Bag serial number 17435184; UDCY31Z UDI-DI 00191072213990 Lot 8043211 Bag serial number 17483121 17483122 17483143 17483144 17485283; UICY28L UDI-DI 191072205537 Lot 8217311 Bag serial number 17598793 * If Bag serial number is listed as "N/A", then whole lot is affected
FEI Number 3007069947
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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