ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
Summary
The FDA issued a Class II for ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy by Boston Scientific Corporation. Reason: Pouch seals may be open, compromising sterility..
Details
Source
Device Recall
External ID
Z-0915-2022
Action Date
2022-04-20
Status
Ongoing
Category
device
Product Description
ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
Lot/Code Info: ROTAWIRE Drive Floppy, 5 pack, UPN: H74939462005 Individual units within 5-pack are labeled as Single, UPN: H74939462001 Batch numbers: 27622475, 27622478, 27691111, 27698472, 27706785, 27708190, 27756019 27756205, 27756933, and 27756935 GTIN: 08714729996255
Quantity Affected: 433 5-packs
Reason for Recall
Pouch seals may be open, compromising sterility.
Distribution
Distribution in the US and territories, Japan, and Canada
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-08
Company
Maple Grove, MN
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 137 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 clearances.
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 (Boston Scientific Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boston Scientific Corporation have FDA actions?
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0915-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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