Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2171-2019Class II

UNIVERSAL BLOCK TRAY Kit Code: MNS6645 -

Centurion Medical Products, LP / initiated 2019-07-01 / Terminated / root cause: manufacturing process

Centurion Medical Products Corporation began a recall of UNIVERSAL BLOCK TRAY Kit Code: MNS6645 - Product Usage: Kit is used for regional anesthesia nerve blocks for general population 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-2171-2019
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Centurion Medical Products, LP
Product
UNIVERSAL BLOCK TRAY Kit Code: MNS6645 - Product Usage: Kit is used for regional anesthesia nerve blocks for general population.
Product code
LRP Tray, Surgical
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
4560 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 # 2019012290 Exp: 7/31/2021

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2171-2019
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2161-2019Class IITerminatedVoluntary: Firm initiated
Z-2162-2019Class IITerminatedVoluntary: Firm initiated
Z-2163-2019Class IITerminatedVoluntary: Firm initiated
Z-2164-2019Class IITerminatedVoluntary: Firm initiated
Z-2165-2019Class IITerminatedVoluntary: Firm initiated
Z-2166-2019Class IITerminatedVoluntary: Firm initiated
Z-2167-2019Class IITerminatedVoluntary: Firm initiated
Z-2168-2019Class IITerminatedVoluntary: Firm initiated
Z-2169-2019Class IITerminatedVoluntary: Firm initiated
Z-2170-2019Class IITerminatedVoluntary: Firm initiated
Z-2171-2019Class IITerminatedVoluntary: Firm initiated
Z-2172-2019Class IITerminatedVoluntary: Firm initiated
Z-2173-2019Class IITerminatedVoluntary: Firm initiated