CLASS II ONGOING Device recall · Reported 2 Sep 2026 · FDA Enforcement Report
Convenience Kit, D & C PACK recalled by American Contract Systems
American Contract Systems is recalling American Contract System Convenience Kit, D & C PACK, distributed nationwide in the US. The recall was initiated on 29 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3003-2026
- FDA event ID
- 99514
- Recalling firm
- American Contract Systems, Tiffin, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Jun 2026
- FDA classified
- 21 Aug 2026
- Reported
- 2 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 29 Jun 2026 | Recall initiated by company | |
| 21 Aug 2026 | Classified by FDA | +53 days |
| 2 Sep 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H
Where it was distributed
US Nationwide distribution in the states of IA, OH.
Questions about this recall
Is Convenience Kit, D & C PACK recalled?
Yes. American Contract Systems recalled Convenience Kit, D & C PACK on 29 Jun 2026. The recall is Class II and its status is Ongoing. Recall number Z-3003-2026.
Why was it recalled?
The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, LP has identified representative samples did not meet applicable performance specifications.
Which lots are affected?
Lot Code: Lot Number: 70-054952 UDI: 191072219947
Where was it sold?
US Nationwide distribution in the states of IA, OH.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from American Contract Systems
All 210| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Convenience Kits, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | Convenience Kit, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | Convenience Kit, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | medical procedure kits and trays labeled as: Crani Pack recalled | American Contract Systems | Sterility | IA, MN, MO |
| Device | CLASS II | medical procedure kits and trays labeled as recalled | American Contract Systems | Sterility | IA, MN, MO |
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