CLASS II ONGOING Device recall · Reported 14 Aug 2024 · FDA Enforcement Report
Hand Pack convenience kit recalled by American Contract Systems
American Contract Systems is recalling American Contract Systems Hand Pack convenience kit, distributed nationwide in the US. The recall was initiated on 6 May 2024 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-2517-2024
- FDA event ID
- 94908
- Recalling firm
- American Contract Systems, Kansas City, MO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 May 2024
- FDA classified
- 7 Aug 2024
- Reported
- 14 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 6 May 2024 | Recall initiated by company | |
| 7 Aug 2024 | Classified by FDA | +93 days |
| 14 Aug 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
American Contract Systems Hand Pack convenience kit
Where it was distributed
US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.
Nationwide CaliforniaKansasMaineMinnesotaMissouriNebraskaSouth Dakota
Questions about this recall
Is Hand Pack convenience kit recalled?
Yes. American Contract Systems recalled Hand Pack convenience kit on 6 May 2024. The recall is Class II and its status is Ongoing. Recall number Z-2517-2024.
Why was it recalled?
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
Which lots are affected?
UDI-DI 00191072203717; Lot 982241;Exp. Date 1/18/2025.
Where was it sold?
US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.
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 | Convenience Kit, D & C 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 |
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