Z-0251-2019Class II
CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000
Manus Medical, LLC / initiated 2018-08-13 / Terminated / root cause: packaging
Custom Healthcare Systems, Inc. began a recall of CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000 on . FDA classified it as Class II and gives the reason as "Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-0251-2019
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Manus Medical, LLC
- Product
- CHS Custom Convenience Kit-LP NEEDLE, 22G X 1 Product Number:NC401000
- Product code
- LRO General Surgery Tray
- Reason for recall
- Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
- Root cause tag
- packaging
- FDA root cause
- Packaging
- Action
- Custom Healthcare Systems (CHS) initiated recall by phone, email and by certified mail on 8/13/18 and carried out to the end user. Custom Healthcare Systems Inc. notified the customers, they were informed to contact their account to receive the product. Product to be returned and credited.
- Quantity in commerce
- 250 units
- Distribution
- Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,
- Product codes and lots
- Lot number: 51018 Exp. Date:5/1/2021
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0240-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0241-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0242-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0243-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0244-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0245-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0246-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0247-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0248-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0249-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0250-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0251-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0252-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0253-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0254-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0255-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0256-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0257-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0258-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0259-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0260-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0261-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0262-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0263-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0264-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0265-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0266-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0267-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0268-2019 | Class II | Terminated | Voluntary: Firm initiated |
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