Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1449-2024Class II

Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Product Code 65140; b) SHARP/SHARP...

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-02-23 / Open, Classified / root cause: manufacturing process

MEDLINE INDUSTRIES, LP - Northfield began a recall of Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Product Code 65140; b) SHARP/SHARP SCISSORS 41/2", Product Code 65840; c) STERILE WIRE... on . FDA classified it as Class II and gives the reason as "Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1449-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Product
Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Product Code 65140; b) SHARP/SHARP SCISSORS 41/2", Product Code 65840; c) STERILE WIRE CUTTER (WCS144), Product Code 66240; d) STERILE LISTER BANDAGE SCISSOR (LS122), Product Code 66855; e) STERILE UTILITY SHEARS (USH176), Product Code 67225; f) STERILE ANGLED BANDAGE SCISSOR (LIST55), Product Code TRI66670
Product code
JOK Scissors, Medical, Disposable
Reason for recall
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
Medline Industries, LP, issued a Medical Device Recall notice to its consignees on 02/27/2024 via email and USPS First Class mail. The notice explained the problem with the devices, risk, and requested that the products be destroyed at the consignee. Distributors were directed to notify their customers.
Quantity in commerce
84224 units
Distribution
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Product codes and lots
a) 65140, UDI/DI 60653160008380 (case) 00653160008388 (each), Lot Numbers: 2023060790, 2023101090; b) 65840, UDI/DI 60653160010208 (case) 00653160010206 (each), Lot Numbers: 2023022790, 2023041190; c) 66240, UDI/DI 60653160008793 (case) 00653160008791 (each), Lot Numbers: 2023112790; d) 66855, UDI/DI 50653160007188 (case) 00653160007183 (each), Lot Numbers: 2023022490, 2023041990, 2023102690; e) 67225, UDI/DI 50653160001766 (case) 00653160001761 (each), Lot Numbers: 2023031690, 2023111490; f) TRI66670, UDI/DI 10653160317975 (case) 20653160317972 (each), Lot Numbers: 2023031490, 2023040690, 2023041090, 2023062790, 2023062890, 2023072490, 2023101690, 2023110190, 2023110990

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1449-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1427-2024Class IIOngoingVoluntary: Firm initiated
Z-1428-2024Class IIOngoingVoluntary: Firm initiated
Z-1429-2024Class IIOngoingVoluntary: Firm initiated
Z-1430-2024Class IIOngoingVoluntary: Firm initiated
Z-1431-2024Class IIOngoingVoluntary: Firm initiated
Z-1432-2024Class IIOngoingVoluntary: Firm initiated
Z-1433-2024Class IIOngoingVoluntary: Firm initiated
Z-1434-2024Class IIOngoingVoluntary: Firm initiated
Z-1435-2024Class IIOngoingVoluntary: Firm initiated
Z-1436-2024Class IIOngoingVoluntary: Firm initiated
Z-1437-2024Class IIOngoingVoluntary: Firm initiated
Z-1438-2024Class IIOngoingVoluntary: Firm initiated
Z-1439-2024Class IIOngoingVoluntary: Firm initiated
Z-1440-2024Class IIOngoingVoluntary: Firm initiated
Z-1441-2024Class IIOngoingVoluntary: Firm initiated
Z-1442-2024Class IIOngoingVoluntary: Firm initiated
Z-1443-2024Class IIOngoingVoluntary: Firm initiated
Z-1444-2024Class IIOngoingVoluntary: Firm initiated
Z-1445-2024Class IIOngoingVoluntary: Firm initiated
Z-1446-2024Class IIOngoingVoluntary: Firm initiated
Z-1447-2024Class IIOngoingVoluntary: Firm initiated
Z-1448-2024Class IIOngoingVoluntary: Firm initiated
Z-1449-2024Class IIOngoingVoluntary: Firm initiated
Z-1450-2024Class IIOngoingVoluntary: Firm initiated
Z-1451-2024Class IIOngoingVoluntary: Firm initiated
Z-1452-2024Class IIOngoingVoluntary: Firm initiated
Z-1453-2024Class IIOngoingVoluntary: Firm initiated
Z-1454-2024Class IIOngoingVoluntary: Firm initiated
Z-1455-2024Class IIOngoingVoluntary: Firm initiated