Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 55 of 138
Arrow International Inc
Class II Terminated
FlexTip Plus Epidural Catheterization Set for Pediatric Lumbar Placement, Product Code EC-05520-P
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1196-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LIN
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1187-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
FlexTip Plus Epidural Catheterization Kit, Product Code TI-05501-ME
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1212-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
EPIDURAL CATHETERIZATION KIT, Product Code UR-05501
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1214-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
EPIDURAL CATHETERIZATION KIT, Product Code BE-080180-CHH
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1192-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
EPIDURAL CATHETERIZATION KIT, Product Code MTO-05500-SU
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1208-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-17019-MSC
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1185-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
FlexTip Plus Epidural Catheterization Kit, Product Code CA-02220
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1193-2020 February 19, 2020 Reading, PA
C.R. Bard Inc
Class II Terminated
The Bard Intra-abdominal Pressure Monitoring Device is composed of a tubing set used for infusing fluid into the urinary bladder through the Foley catheter sampling port. It utilizes a clamping device...
Reason: Leaks or disconnect near the sampling port of the Intra Abdominal Pressure Monitoring Device which could lead to the potential of inaccurate readings. The measurement should be co...
Z-1219-2020 February 19, 2020 Covington, GA
Arrow International Inc
Class II Terminated
EPIDURAL CATHETERIZATION KIT, Product Code CZ-05400-EPI
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1194-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
EPIDURAL CATHETERIZATION KIT, Product Code AT-05501-LEO
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1186-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code NYU-05500-1
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1211-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05560-TG1
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1183-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
FlexTip Plus Epidural Catheterization Kit, Product Code YC-02220
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1217-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
EPIDURAL CATHETERIZATION KIT, Product Code DE-05400D-BO
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1195-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
FlexTip Plus Combined Spinal Epidural Catheterization Kit, Product Code ASK-05500-BID
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1178-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
FlexTip Plus Epidural Catheterization Kit, Product Code MP-17019-TKP
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1207-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
Epidural Catheterization Kit with FlexTip Plus, Open Tip, Single- Port Catheter, Product Code ASK-05502-NY
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1181-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
FlexTip Plus Epidural Catheterization Kit, Product Code ASK-02220-SRH
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1174-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
EPIDURAL CATHETERIZATION KIT, Product Code FR-05501-10
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1198-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
EPIDURAL CATHETERIZATION KIT, Product Code BE-05400-DCHH
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1189-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
EPIDURAL CATHETERIZATION KIT, Product Code BE-05400B-ETTEL
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1188-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
FlexTip Plus Combined Spinal Epidural Catheterization Set, Product Code AA-05400-B
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1170-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
FlexTip Plus Epidural Catheterization Set, Product Code MTO-05500-TK
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1209-2020 February 19, 2020 Reading, PA
Arrow International Inc
Class II Terminated
Epidural Catheterization Kit with FlexTip Plus Catheter, Product Code TI-05520-EPI
Reason: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Z-1213-2020 February 19, 2020 Reading, PA