Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0824-06

Hobbs Medical 3 Prong Looped Retriever, a disposable device to be used by physician to remove foreign object...

Hobbs Medical, Inc. / initiated 2006-03-15 / Terminated / root cause: manufacturing process

Hobbs Medical, Inc. began a recall of Hobbs Medical 3 Prong Looped Retriever, a disposable device to be used by physician to remove foreign object or cauterize polyp specimens from the GI tract... on . The reason FDA records is "Diameter of device at the distal end would prevent it from passing through the endoscope's working channel". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0824-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hobbs Medical, Inc.
Product
Hobbs Medical 3 Prong Looped Retriever, a disposable device to be used by physician to remove foreign object or cauterize polyp specimens from the GI tract. REF: 5030 and 5030S
Product code
KOG
Reason for recall
Diameter of device at the distal end would prevent it from passing through the endoscope's working channel.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
Hobbs Medical notfied customers by Registered Letter on 3/15/06, requesting return of recalled product.
Quantity in commerce
254 units
Distribution
AK, IA, KY, MI, NH, NC,UT, WI, Canada, and UK
Product codes and lots
Lot Numbers: H11-05-040; H11-05-138; H11-05-139; H11-05-140;H11-05-141; H11-05-205.