Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. K
Summary
The FDA issued a Class II for Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the foll 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-2163-2021
Action Date
2021-08-04
Status
Ongoing
Category
device
Product Description
Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIR 23/05, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/05N, Length 50 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/07, Length 75 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/07N, Length 70 mm, Diameter 23 G (0.6 mm); Article no. KIR 23/10, Length 100 mm, Diameter 23G (0,6mm); Article no. KIR 23/15, Length 150 mm, Diameter 23 G (0.6 mm); Article no. KIR 21/10, Length 100 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/12, Length 120 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/15, Length 150 mm, Diameter 21 G (0.8 mm); Article no. KIR 21/20, Length 200 mm, Diameter 21 G (0.8 mm); Article no. KIR 17/15, Length 150 mm, Diameter 17 G (1.40mm) Article no. KIR 17/15:45, Length 150 mm, Diameter 17 G (1.40mm) *NOT DISTRIBUTED WITHIN THE US
Lot/Code Info: Affected Lot Numbers: KIR 23/05: LOT: 2516, 5016, 1417, 0718, 3318, 4318, 3819, 1520; KIR 23/05N: LOT: 0717, 5117, 0518, 4318, 1520; KIR 23/07: LOT: 2516, 4216, 3617, 0718, 3318, 4318, 2119, 3819, 1520, 3320, 4420; KIR 23/07N: LOT: 2916, 4516, 5016, 0717, 1618, 4318, 3819, 1520, 5220; KIR 23/10: LOT: 2016, 2916, 4016, 5016, 0417, 0817, 0917, 1417, 2117A, 2117B, 3917, 4217, 4317, 4517,1618, 4118, 3318, 4818, 4318, 0319, 3319, 4119, 4619, 0520, 1620, 4420, 5220 KIR 23/15: LOT: 1417, 0418, 3319, 2420; KIR 21/10: LOT: 2916, 4016, 1417, 2117A, 2117B, 0418, 4318, 0719, 2119, 3519, 4619,1020, 1620, 5220; KIR 21/12: LOT: 2116, 0717, 1618, 2119, 4619, 1020, 3820; KIR 21/15: LOT: 3416, 0717, 1417, 0418, 3318, 4318, 3819, 1020, 3820; KIR 21/20: LOT: 3617, 1020; KIR17/15: LOT: 2417, 5117, 0918; KIR17/15:45: LOT: 3616, 4216, 2317, 5117, 0918, 3919, 2720;
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-2163-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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