Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BI
Summary
The FDA issued a Class II for Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the follo by INNOVATIVE TOMOGRAPHY PRODUCT GMBH. Reason: Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized.
Details
Source
Device Recall
External ID
Z-2164-2021
Action Date
2021-08-04
Status
Ongoing
Category
device
Product Description
Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. BIM 18/10, Length 100 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/15, Length 150 mm, Diameter 18 G (1.25 mm); Article no. BIM 18/20, Length 200 mm, Diameter 18 G (1.25 mm); Article no. BIM 16/10, Length 100 mm, Diameter 16 G (1.6 mm); Article no. BIM 16/15, Length 150 mm, Diameter 16 G (1.6 mm); Article no. BIM 16/20, Length 200 mm, Diameter 16 G (1.6 mm); Article no. BIM 14/10, Length 100 mm, Diameter 14 G (2.1 mm); Article no. BIM 14/15, Length 150 mm, Diameter 14 G (2.1 mm); Article no. BIM 14/20, Length 200 mm, Diameter 14 G (2.1 mm) *NOT DISTRIBUTED WITHIN THE US
Lot/Code Info: Affected Lot Numbers: BIM 18/10: LOT: 4918; BIM 18/15: LOT: 4017, 4918, 4719; BIM 18/20: LOT: 4017, 4918; BIM 16/10: LOT: 4918, 1119, 1219; BIM 16/15: LOT: 4918, 1119; BIM 16/20: LOT: 4918, 1119; BIM 14/10: LOT: 4918, 3019; BIM 14/15: LOT: 4918; BIM 14/20: LOT: 4918
Quantity Affected: N/A
Reason for Recall
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
Distribution
US Nationwide distribution in the state of CA.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-04-21
Company
Bochum, N/A
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 173 device recalls issued in the same week, part of 403 device-related FDA actions this month.
INNOVATIVE TOMOGRAPHY PRODUCT GMBH has 3 FDA actions in our database, including 3 recalls.
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 (INNOVATIVE TOMOGRAPHY PRODUCT GMBH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does INNOVATIVE TOMOGRAPHY PRODUCT GMBH have FDA actions?
INNOVATIVE TOMOGRAPHY PRODUCT GMBH has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2164-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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