Summary
The FDA issued a Class II for Hobbs Medical Polypectomy Snare, Catalog No. 7202 by Hobbs Medical, Inc.. Reason: During use, the sheath of the device may accordion at the proximal end where the sheath meets the shrink band. Kinking of the sheath may prevent the s.
Details
Source
Device Recall
External ID
Z-1388-2022
Action Date
2022-07-27
Status
Ongoing
Category
device
Product Description
Hobbs Medical Polypectomy Snare, Catalog No. 7202
Lot/Code Info: UDI-DI: M84972020 Package UDI: M84972021 Lots: H11-20-017 H04-20-062 H04-19-056 H11-19-077 H08-17-014R H10-17-089R H10-17-089 H0S-17-014 H06-17-167
Quantity Affected: 45 (US)
Reason for Recall
During use, the sheath of the device may accordion at the proximal end where the sheath meets the shrink band. Kinking of the sheath may prevent the snare from fully closing, and injury may result.
Distribution
Domestic distribution to NC, TX, and WA. Foreign distribution to Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-03
Company
Stafford Springs, CT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Hobbs Medical, Inc. has 73 FDA actions in our database, including 72 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hobbs Medical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hobbs Medical, Inc. have FDA actions?
Hobbs Medical, Inc. has 73 FDA actions in our database, including 72 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1388-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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