Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS ...
Reason for Recall / Hazard
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss.
Product Description & Identification
Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS982269L CDS982269M CDS982269N CARDIAC MAJOR DYNJ901328D DYNJ901328F HEART A DYNJ903465F DYNJ903465G HEART TRAY-VASCULAR DYNJ907857 DYNJ907857A DYNJ907857B KIT UNIVERSITY CABG PK DYNJ905857A OPEN HEART CDS981161AA CDS981161AB DYNJ905437A DYNJ909090 DYNJ909090C DYNJ9855016R DYNJ9855016S OPEN HEART ACCESSORY CDS CDS984289J OPEN HEART ANESTHESIA PACK CDS983849D CDS983849F CDS983849G OPEN HEART B CDS DYNJ900377P OPEN HEART BASIC B DYNJ904311C OPEN HEART CDS CDS983513F OPEN HEART CDS QVH CDS982523K CDS982523L CDS982523N OPEN HEART LINE SET UP DYNJ908179 DYNJ908179A OPEN HEART SUPPLEMENT DYNJ909116 DYNJ909116A DYNJ909116C DYNJ909116D SILVER CROSS OPEN HEART DYNJ906102J DYNJ906102K DYNJ906102L SM OPEN HEART PACK A&B DYNJ904749G DYNJ904749J VPH OPEN HEART DYNJ902664J DYNJ902664K DYNJ902664L
Affected Products
Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS982269L CDS982269M CDS982269N CARDIAC MAJOR DYNJ901328D DYNJ901328F HEART A DYNJ903465F DYNJ903465G HEART TRAY-VASCULAR DYNJ907857 DYNJ907857A DYNJ907857B KIT UNIVERSITY CABG PK DYNJ905857A OPEN HEART CDS981161AA CDS981161AB DYNJ905437A DYNJ909090 DYNJ909090C DYNJ9855016R DYNJ9855016S OPEN HEART ACCESSORY CDS CDS984289J OPEN HEART ANESTHESIA PACK CDS983849D CDS983849F CDS983849G OPEN HEART B CDS DYNJ900377P OPEN HEART BASIC B DYNJ904311C OPEN HEART CDS CDS983513F OPEN HEART CDS QVH CDS982523K CDS982523L CDS982523N OPEN HEART LINE SET UP DYNJ908179 DYNJ908179A OPEN HEART SUPPLEMENT DYNJ909116 DYNJ909116A DYNJ909116C DYNJ909116D SILVER CROSS OPEN HEART DYNJ906102J DYNJ906102K DYNJ906102L SM OPEN HEART PACK A&B DYNJ904749G DYNJ904749J VPH OPEN HEART DYNJ902664J DYNJ902664K DYNJ902664L
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 99209 |
| Address 1 | 3 Lakes Dr |
| Address 2 | N/A |
| Code info | CDS982269K UDI-DI 10193489906844 Lots 21HBN691 21JBQ518 21LBD444 CDS982269L UDI-DI 10195327018016 Lots 21LBP501 22ABR514 22BBE936 22FBV989 CDS982269M UDI-DI 10195327192808 Lots 22JBE028 22LBF124 23ABP909 23CBO580 CDS982269N UDI-DI 10195327352998 Lots 23GBC969 23HBS959 23KBW067 23LBF510 24CBO691 24DBR250 24EBU619 24GBF288 25ABM339 25CBJ666 25HBH657 25IBM477 26BBG451 DYNJ901328D UDI-DI 10193489854923 Lots 21CBQ397 21FBJ935 21HBR220 21JBV897 21JBV898 22ABG611 DYNJ901328F UDI-DI 10195327044572 Lots 22CBX749 22FBX103 23ABC195 23EBG860 23EBL637 23EBS968 23FBM688 23GBS043 24EBL355 24FBJ301 24IBS567 24JBD767 24JBU518 24KBL806 24LBF815 25DBF590 25FBQ740 25GBH267 25JBQ634 DYNJ903465F UDI-DI 10193489918397 Lots 21FDB453 21HDB016 21IDB927 21KDA273 21LDA283 21LDB750 22CDA262 DYNJ903465G UDI-DI 10195327175559 Lots 22FDA593 22IDA677 22KDA077 ... [TRUNCATED] |
| Postal code | 60093-2753 |
| Report date | 20260708 |
| Product type | Devices |
| Product quantity | 9,272 kits |
| Reason for recall | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260528 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260626 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI.