FDA-Device2026-05-27Class IIPROCESSING DEFECT
Becton Dickinson Swan-Ganz Jr Catheter recalled for proximal hub leak and break risk
What this means
Certain Swan-Ganz Jr Catheter models may leak or break at the blue proximal injectate lumen hub due to manufacturing and material changes. This can result in infection, loss of medication, or blood loss during use.
- Check if you have one of the affected models: SGPT54, SGPT64P, or SGPT755P.
- Review the UDI and expiration dates on your catheter package to see if it matches the recalled lots.
- Contact Becton Dickinson or your healthcare provider for guidance on affected units in your facility.
The agency's original wording
Hazard
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution including in the states of TX, SC, CT, GA, VA, MO, NM, UT, NJ, CA, FL, PA, IN, TN, WA, KY, MD, WV, MI, MA, NC, MN, NY, AZ, AL, LA, CO, OK, HI, MS, IL, OH, NE, DC, KS, NV, WI, SD, IA, AR, ID, OR, WY, MT, RI, VT, DE, AK, NH, ND, ME, PR and the countries of Japan, Brazil, Colombia, Australia, New Zealand, Poland, Czech Republic, South Africa, Mauritius, Germany, Israel, Iran, Slovakia, Switzerland, Slovenia, Bulgaria, Cyprus, Saudi Arabia, United Arab Emirates (UAE), Kuwait, Malta, Bahrain, Qatar, Hungary, Morocco, Romania, Lebanon, Tunisia, Oman, Turkey, Austria, Belgium, Luxembourg, France, Netherlands, Italy, Spain, Canary Islands, Portugal, United Kingdom, Northern Ireland, Ireland, Denmark, Sweden, Iceland, Norway, Estonia, Finland, Greece, Chile, Puerto Rico, Canada.
Affected count
183
Manufactured in
17200 Laguna Canyon Rd, Irvine, CA, United States
Products
Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2203-2026Want us to check the next one for you?
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