MEDRAD Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
Bayer Medical Care, Inc. · Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
Open FDA's page for this record- Cfres ID
- 222232
- Product res number
- Z-3147-2026
- Event date initiated
- 2026-07-31
- Event date posted
- 2026-09-11
- Recall status
- Open, Classified
- Res event number
- 99698
- Product code
- DXT
- Product description
- MEDRAD Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT;
- Code info
- Catalog number: FLEXS-150-QFT; UDI-DI: 00616258022895; Affected material number: 87078825; Affected batch number: 8688750;
- Firm FEI number
- 2520313
- Recalling firm
- Bayer Medical Care, Inc.
- Address 1
- 1 Bayer Dr
- City
- Indianola
- State
- PA
- Postal code
- 15051-9702
- Additional info contact
- Lindsay Metkler 412-406-2153
- Reason for recall
- Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
- Root cause description
- Employee error
- Product quantity
- 27800 kits (556 boxes)
- Distribution pattern
- US Nationwide distribution.
- Action
On or about July 31, 2026, consignees were notified via telephone followed by sending URGENT MEDICAL DEVICE RECALL letters. Actions to be taken: 1. Review your inventory for affected product and to quarantine any loose/unboxes product from the lot. 2. Whether or not Box 0855 of Lot 8688750 is found to be in your inventory/possession, we will need you to please confirm that information for our records by filling out and returning the response form provided. 3. Please distribute this letter to other appropriate departments and personnel within your facility who may need awareness of this recall.
- K numbers
- K182273
- Harmonized identifiers (openFDA)
- Device name
- Injector And Syringe, Angiographic
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1650
- Device class
- 2
- K number
- K993774, K991557, K903390, K042784, K201395, K052744, K241109, K863596, K905819, K903494, K140425, K833138, K242212, K873410, K152978, K142081, K061976, K883769, K093830, K132928, K823190, K252638, K841493, K960430, K880310, K912944, K991103, K962141, K971712, K151960, K190102, K932083, K890292, K823920, K083523, K955684, K152906, K911549, K880877, K993728 +170 more
- Registration number
- 3042190142, 9616990, 2032098, 3012127758, 3015225571, 1526863, 3007289408, 3010131137, 9616567, 3045750327, 3006950086, 3018094310, 2249018, 3013764800, 3010934635, 3003542872, 3006791331, 3032902763, 1047843, 1518293, 3011334555, 3012536737, 3011642792, 3015183635, 3004080920, 1043214, 3013413516, 2134243, 1055236, 3031503890, 3007361214, 3011604145, 3003786696, 3004727093, 3002808086, 2936999, 3034544377, 1038185, 3014246639, 3004056159 +88 more
- FEI number
- 3042190142, 3002806315, 3012127758, 3015225571, 1000219637, 1526863, 3007289408, 3010131137, 3045750327, 3006950086, 3018094310, 1000112968, 3013764800, 1000114111, 3010934635, 3003542872, 3006791331, 3000718866, 3032902763, 1047843, 1518293, 3011334555, 3012536737, 3003058448, 3011642792, 3015183635, 3004080920, 1043214, 3013413516, 1000514656, 3031503890, 3007361214, 3011604145, 3003786696, 3003094575, 3004727093, 3002808086, 2936999, 3034544377, 1038185 +88 more