medical Class II Updated 2021-08-04

INNOVATIVE TOMOGRAPHY PRODUCT GMBH recalls Coaxial Interventional Needle, ITP innotom.com, CE 0297, STE

Recalled 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 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

Hazard / Issue

Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized

Issued by

FDA

Distribution: Nationwide (United States)

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;

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