510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-1436-2024Class II

Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825; b) STERILE PAS...

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-02-23 / Open, Classified / root cause: manufacturing process
FDA source (opens on fda.gov)

MEDLINE INDUSTRIES, LP - Northfield began a recall of Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825; b) STERILE PAS #3 BLADE HANDLE (BH3PAS), Product Code I68290 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-1436-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Product
Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code 66825; b) STERILE PAS #3 BLADE HANDLE (BH3PAS), Product Code I68290
Product code
GDZ Handle, Scalpel
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
3860 units
Distribution
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Product codes and lots
a) 66825, UDI/DI 60653160053588 (case) 00653160053586 (each), Lot Numbers: 2023091990, 2023111590; b) I68290 UDI/DI 00653160275056 (case) 10653160275053 (each), Lot Numbers: 2023100690

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1436-2024
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