Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(803…
Atrium Medical Corporation · An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
Open FDA's page for this record- Cfres ID
- 222193
- Product res number
- Z-3111-2026
- Event date initiated
- 2026-08-07
- Event date posted
- 2026-09-04
- Recall status
- Open, Classified
- Res event number
- 99680
- Product code
- GBZ
- Product description
- Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2. 24FR(8024), 3. 28FR(8028), 4. 32FR(8032), 5. 36FR(8036);
- Firm FEI number
- 3011175548
- Recalling firm
- Atrium Medical Corporation
- Address 1
- 40 Continental Blvd
- City
- Merrimack
- State
- NH
- Postal code
- 03054-4332
- Additional info contact
- Megan Ties 603-880-1433
- Reason for recall
- An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
- Root cause description
- Nonconforming Material/Component
- Product quantity
- 3618
- Distribution pattern
- US Nationwide distribution.
- Code info
1. Model Number(Size): 8016(16FR); UDI-DI: 00650862130164; Lot Number: ME244878; 2. Model Number(Size): 8024(24FR); UDI-DI: 00650862130249; Lot Number: ME244835; 3. Model Number(Size): 8028(28FR); UDI-DI: 00650862130287; Lot Numbers: ME244682, ME244836, ME244837, ME244681; 4. Model Number(Size): 8032(32FR); UDI-DI: 00650862130324; Lot Number: ME244840; 5. Model Number(Size): 8036(36FR); UDI-DI: 00650862130362; Lot Number: ME244686;
- Action
On August 7, 2026 URGENT MEDICAL DEVICE - RECALL letters were sent to customers. Customer Actions: 1. Please examine your inventory immediately to determine if you have any of the Atrium PVC Thoracic Catheters with the specific lot numbers. 2. Should you have any affected product, please remove from area(s) of use and quarantine. 3. Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected devices have been transferred. 4. Please contact Contact Customer Service via email at customersupport.us@getinge.com or 888-943-8872, option 2 / (888 9GETUSA), Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. (Eastern Time Zone) to request a return authorization (RMA) and shipping instructions to return any affected product. 5. Whether or not you have affected product(s) within expiration listed in this notice, please complete and sign the attached MEDICAL DEVICE- REMOVAL RESPONSE FORM to acknowledge that you have received this notification. Return the completed form to Getinge by e-mailing a copy to recallresponses.qrc@getinge.com.
- Harmonized identifiers (openFDA)
- Device name
- Catheter, Cholangiography
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4200
- Device class
- 1
- K number
- K926217, K830711, K973621, K873471, K831931, K924212, K870420, K944790, K924981, K860534, K772288, K921091, K925742, K895285, K914015, K926143, K932228, K920643, K903709, K924480, K833059, K942450, K924128, K901520
- Registration number
- 9616567, 3009495876, 3004638532, 1223009, 3013162291, 1828132, 3005273623, 1828424, 2431166, 1055890, 1000121056, 1043214, 3010041511, 3004111573, 9616088, 9680515, 3043007473, 9680794, 1820334, 1220477, 3021767551, 3010131137, 3007695959, 1825146, 3015997711, 3011137372, 1423537, 9681260, 1000151187, 8010877, 3004365956, 3003915875, 8010298, 1062668, 1643817, 3012104670, 1211566, 2424366, 1836161, 1061124 +16 more
- FEI number
- 3009495876, 3004638532, 1000111204, 3002902735, 3013162291, 1828132, 3005273623, 1828424, 1000121056, 1043214, 3010041511, 3004111573, 1000120560, 3043007473, 1820334, 1220477, 3021767551, 3002750084, 3010131137, 3007695959, 1825146, 3015997711, 1000151187, 3004365956, 3003915875, 3005969827, 1643817, 3012104670, 1211566, 3001639746, 2424366, 3006509795, 3011175548, 3005747797, 2936485, 3005012805, 2523865, 3003898360, 3009513193, 3014579161 +16 more