Z-2164-2019Class II
CIRCUMCISION TRAY Kit Code: CIT2650H -
Centurion Medical Products, LP / initiated 2019-07-01 / Terminated / root cause: manufacturing process
Centurion Medical Products Corporation began a recall of CIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is used for performing circumcision procedures on newborns on . FDA classified it as Class II and gives the reason as "Potential for sterile packaging to be compromised". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2164-2019
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Centurion Medical Products, LP
- Product
- CIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is used for performing circumcision procedures on newborns.
- Product code
- OHG Circumcision Tray
- Reason for recall
- Potential for sterile packaging to be compromised
- Root cause tag
- manufacturing process
- FDA root cause
- Employee error
- Action
- 1) Please identify all inventory that you have within your possession and segregate the recalled product. 2) Please complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter as directed. Upon receipt of this record, your response will be documented, and a Centurion Representative will contact you regarding retrieval of the product from your facility, if required. 3) Please forward a copy of this notice to any facilities to whom this product may have been further distributed. Please contact the number for any question (517) 546-5400 Ext.1122.
- Quantity in commerce
- 168 each
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, GA, IL, KY, MA, MD, MI, NC, NH, NY, OH, SC, TX, TN, VA, WA, WI.
- Product codes and lots
- Lot # 2019051390 Exp: 8/31/2021
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2161-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2162-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2163-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2164-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2165-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2166-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2167-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2168-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2169-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2170-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2171-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2172-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2173-2019 | Class II | Terminated | Voluntary: Firm initiated |
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