Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article num...
FDA Device Recall #Z-2162-2021 — Class II — April 21, 2021
Recall Summary
| Recall Number | Z-2162-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 21, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | INNOVATIVE TOMOGRAPHY PRODUCT GMBH |
| Location | Bochum, N/A |
| Product Type | Devices |
| Quantity | N/A |
Product Description
Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers: Article no. KIM 22/05, Length 50 mm, diameter 22G/0,7 mm; Article no. KIM 22/07,Length 75 mm, diameter 22 G (0.7 mm); Article no. KIM 22/10, Length 100 mm, diameter 22 G (0.7 mm); Article no. KIM 20/15, Length 150 mm, diameter 20 G (0.9 mm); Article no. KIM 18/10, Length 100 mm, diameter 18 G (1.25 mm); Article no. KIM 18/10T, Length 100 mm, diameter 18 G (1.25 mm); Article no. KIM 18/15, Length 150 mm, diameter 18 G (1.25 mm); Article no. KIM 18/15T, Length 150 mm, diameter 18 G (1.25 mm); Article No. KIM 18/20, Length 200 mm, diameter 18G/1.27mm, Article no. KIM 13/04T, Length 44 mm, diameter 13 G (2.40 mm); Article no. KIM 13/09T, Length 94 mm , diameter 13 G (2.40 mm); Article no. KIM 13/14T, Length 144 mm, diameter 13 G (2.40 mm); Article no. KIM 15/04T, Length 44 mm, diameter 15 G (1.95 mm); Article no. KIM 15/09T, Length 94 mm, diameter 15 G (1.95 mm); Article no. KIM 15/14T, Length 144 mm, diameter 15 G (1.95 mm); Article no. KIM 16/04T,Length 44 mm, diameter 16 G (1.60 mm); Article no. KIM 16/09T, Length 94 mm, diameter 16 G (1.60 mm); Article no. KIM 16/14T, Length 144 mm, diameter 16 G (1.60 mm); Article no. KIM 14/20T, Length 200 mm, Diameter 14 G (2.1 mm)
Reason for Recall
Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized
Distribution Pattern
US Nationwide distribution in the state of CA.
Lot / Code Information
Affected Lot Numbers: KIM 22/05: LOT: 3416, 5016, 0717, 1417, 4117, 4217, 0418, 2818, 2119, 4619A, 3819, 0220A, 0220B, 0220C, 2420, 3820; KIM 22/07: LOT: 4216, 0717, 1417, 4918, 2119, 4619A, 4319, 0220A, 0220B, 3820; KIM 22/10: LOT: 3616, 5016, 0717, 1417, 0418, 1118, 2818, 2119, 2419, 4619A, 0220A, 0220B, 0220C, 4319, 1220, 1020, 2720, 3520; KIM 22/15: LOT: 1417, 2118,4319; KIM 20/10: LOT: 4318; KIM 20/15: LOT: 4318; KIM 18/10: LOT: 0717, 4318; KIM 18/10T: LOT: 0217; KIM 18/15: LOT: 0717, 4318, 0920; KIM 18/15T: LOT: 4318; KIM 18/20: LOT: 4318; KIM 13/04T: LOT: 0817, 4318; KIM 13/09T: LOT: 0817, 4318; KIM 13/14T: LOT: 0817, 4318; KIM 15/04T: LOT: 2818; KIM 15/09T: LOT: 2818; KIM 15/14T: LOT: 2818; KIM 16/04T: LOT: 2818, 4820; KIM 16/09T: LOT: 2818, 4820, 5020; KIM 16/14T: LOT: 2818, 4820; KIM 14/20T: LOT: 2419;
Other Recalls from INNOVATIVE TOMOGRAPHY PRODUCT GMBH
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2164-2021 | Class II | Semi-automatic Biopsy-Needle, ITP innotom.com, ... | Apr 21, 2021 |
| Z-2163-2021 | Class II | Coaxial Interventional Needle, ITP innotom.com,... | Apr 21, 2021 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.