CLASS II Device recall · Reported 30 Nov 2022 · FDA Enforcement Report
Basin SET, MEBS42K, general surgical kit recalled
American Contract Systems is recalling Basin SET, MEBS42K, general surgical kit, distributed nationwide in the US. The recall was initiated on 12 Oct 2022 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-0274-2023
- FDA event ID
- 91077
- Recalling firm
- American Contract Systems, Kansas City, MO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Oct 2022
- FDA classified
- 22 Nov 2022
- Reported
- 30 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Surgical Instruments
Timeline
| 12 Oct 2022 | Recall initiated by company | |
| 22 Nov 2022 | Classified by FDA | +41 days |
| 30 Nov 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the contents of the package do not match the contents listed on the label.
Product as listed by the FDA
BASIN SET, MEBS42K, general surgical kit
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Basin SET, MEBS42K, general surgical kit recalled?
Yes. American Contract Systems recalled Basin SET, MEBS42K, general surgical kit on 12 Oct 2022. The recall is Class II and its status is Terminated. Recall number Z-0274-2023.
Why was it recalled?
Basin Set labeling error: components within the kit are for the Single Basin Set. Therefore, the contents of the package do not match the contents listed on the label.
Which lots are affected?
UDI/DI 00191072151742, Batch/Lot No. 833221, exp 6/16/2023
Where was it sold?
US Nationwide distribution.
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
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|---|---|---|---|---|---|
| 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 |
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| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |