Medical convenience kits containing BD CliniClean Pericare… recallZ-3293-2026 · American Contract Systems Inc · initiated Aug 10, 2026
Open, Classified
Is my device affected?
- 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.
- 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.
- 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
Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare due to disposal of contaminated wipes may increase risk of localized infection or catheter-associated urinary tract infection (CAUTI).
FDA root cause category: Under Investigation by firm
What the company is doing
Firm began notifying affected distributors via email on August 10, 2026. Distributors were instructed to notify end-users. Customers were instructed to identify, segregate, and quarantine all impacted products. Customers are to add recall labels to affected kits to ensure the impacted component is discarded prior to use. An amended customer letter was sent out on August 28, 2026, which added the following instruction: Users should source alternative cleansing wipes for the impacted product lots and ensure they continue to follow their facility protocols for providing perineal care for patients with urinary catheters.
Recall details
- Recall number
- Z-3293-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 10, 2026
- Posted by the FDA
- Sep 25, 2026
- Recalling firm
- American Contract Systems Inc
- Quantity
- 1,804 kits total
- Product code
- OEZ
- Distribution
- US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota.
Product description
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays CARDIAC HEART BUNDLE NS Model No. LMCH99P OPEN HEART 2 RCH 0248495 Model No. RCOH62C
Code information (models, lots, serial numbers)
LMCH99P UDI-DI 191072228147 Lots 42-8533511 42-8669111 42-8763811 42-8811311 42-8825411 42-8869411 RCOH62C UDI-DI 191072230942 Lots 42-8504411 42-8561511 42-8668211 42-8737811 42-8797911 42-8862511
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- ACS LMCH99PAmerican Contract Systems, Inc. · Cardiovascular procedure kit1 recall0 reports
- ACS RCOH62CAmerican Contract Systems, Inc. · Cardiovascular procedure kit1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99759).
- Z-3292-2026 · Open, ClassifiedMedical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88AO
- Z-3294-2026 · Open, ClassifiedMedical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECTOMY - 205989 Model No. MHAH55AM LAVH-LAP COLON Model No.…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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