| Date Initiated by Firm | March 15, 2006 |
|---|
| Date Posted | May 03, 2006 |
|---|
| Recall Status1 |
Terminated 3 on June 27, 2006 |
| Recall Number | Z-0824-06 |
|---|
| Recall Event ID |
35011 |
| 510(K)Number | K833125 |
|---|
| Product Classification |
unknown device name - Product Code KOG
|
| 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 |
|---|
| Code Information |
Lot Numbers: H11-05-040; H11-05-138; H11-05-139; H11-05-140;H11-05-141; H11-05-205. |
| FEI Number |
1220592
|
Recalling Firm/
Manufacturer |
Hobbs Medical, Inc.
8 Spring St
Stafford Springs
CT
06076-1505
|
| For Additional Information Contact | Robert J. Coles
860-684-5875 |
|---|
Manufacturer Reason
for Recall | Diameter of device at the distal end would prevent it from passing through the endoscope's working channel. |
|---|
FDA Determined
Cause 2 | Process control |
|---|
| Action | Hobbs Medical notfied customers by Registered Letter on 3/15/06, requesting return of recalled product. |
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| Quantity in Commerce | 254 units |
|---|
| Distribution | AK, IA, KY, MI, NH, NC,UT, WI, Canada, and UK |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
|
| 510(K) Database | 510(K)s with Product Code = KOG
|
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