FDA Recall
Terminated
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
Recall: Z-0824-06
·
Initiated March 15, 2006
Recall
- Recall Number
- Z-0824-06
- Event Number
- 35011
- Firm
- Hobbs Medical, Inc.
- FEI Number
- 1220592
- Product Code
- KOG
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- March 15, 2006
- Posted
- May 3, 2006
- Terminated
- June 27, 2006
- Address
- 8 Spring St, Stafford Springs, CT, 06076-1505
Description
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
Reason
Diameter of device at the distal end would prevent it from passing through the endoscope's working channel.
Action
Hobbs Medical notfied customers by Registered Letter on 3/15/06, requesting return of recalled product.
Distribution
AK, IA, KY, MI, NH, NC,UT, WI, Canada, and UK
Quantity
254 units