INNOVATIVE TOMOGRAPHY PRODUCT GMBH Recall 88213
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
INNOVATIVE TOMOGRAPHY PRODUCT GMBH Recall 88213 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-2164-2021 |
Event ID | 88213 |
Event 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 |
Product Type | Devices |
Distribution | US Nationwide distribution in the state of CA. |
Recall Reason | Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized |
Device Classification | 20210804 |
Device 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 |
Center Classification Date | 20210729 |
Recall Initiation Date | 20210421 |
Recalling Firm | INNOVATIVE TOMOGRAPHY PRODUCT GMBH |
Initial Notification | |
Similar To |