Coaxial Interventional Needle recall: Sterility Concern
Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIR 23/05, Length 50 mm, Diameter…
Why was Coaxial Interventional Needle recalled?
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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;
- Product
- Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIR 23/05, Length 50 mm, Diameter…
- Recalling firm
- INNOVATIVE TOMOGRAPHY PRODUCT GMBH
- Quantity
- N/A
- Distribution
- US Nationwide distribution in the state of CA.
- Recall date
- August 4, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)