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Medical convenience kits recallZ-0176-2026 · American Contract Systems Inc. · initiated Sep 4, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from American Contract Systems Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Nonconforming Material/Component

What the company is doing

Firm 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.

Recall details

Recall number
Z-0176-2026
Status
Open, Classified
Initiated by the company
Sep 4, 2025
Posted by the FDA
Oct 16, 2025
Recalling firm
American Contract Systems Inc.
Quantity
32,433 total
Product code
OEZ
Distribution
US Nationwide distribution in the states of SD, IA, MN, WA, IL.

Product description

Medical convenience kits Item Number/Description ANCV78BC HEART PACK - 205947 HGCV05K CV SET UP PACK MHPP97AR PACEMAKER PACK- 206010 UDBH37AW BASIC HEART PACK - 206044 UHPP82AH PERIPHERAL PACK - 209533 UICD62AN CARDIOVASCUALR SUPPLY (PS 907285) UICT16F CARDIO THORACIC DRAPE PACK (PS 907284) UIVA75I VASCULAR PACK

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

ANCV78BB UDI-DI 191072214362 Lot 8133811 Bag serial number 68273380; ANCV78BC UDI-DI 191072235169 Lot 8499811 Bag serial numbers N/A; HGCV05K UDI-DI 191072212474 Lot 8021411 Bag serial number 68154464; MHPP97AR UDI-DI 191072237446 Lot 8527511 Bag serial number N/A; UDBH37AW UDI-DI 191072235299 Lot 8194311 Bag serial numbers 68198334 68198335; UHPP82AH UDI-DI 191072216434 Lot 8112811 Bag serial number N/A; UICD62AN UDI-DI 191072200495 Lot 7999011 Bag serial number N/A; UICT16F UDI-DI 191072150431 Lot 8000411 Bag serial number N/A Lot 8331311 Bag serial number 17627819 Lot 8429011 Bag serial number 17749736; UIVA75I UDI-DI 191072229052 Lot 8056011 Bag serial number N/A; UIVA75J UDI-DI 191072235602 Lot 8422011 Bag serial number 68667536 * If Bag serial number is "n/a", then all of that lot is affected

Devices named in this recall

10 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 97659).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page