FDA · Medical device recall

DTX(tm) Plus DT-DL60 Continuous flush catheter and 6 more products

Oct. 21, 2005

Date posted by the FDA: Oct. 21, 2005
Status: Terminated
Filed by: Becton Dickinson Medical Systems
Reason: Device could permit an over-infusion of IV solutions during pressure monitoring procedures.
Distribution pattern: Nationwide, including PR. VA facilities in OH, WA, NV and NY. No military or foreign distribution by US firm..

7 products in this recall

DTX(tm) Plus DT-DL60 Continuous flush catheter

Product: DTX(tm) Plus DT-DL60 Continuous flush catheter
Quantity: 6725 units
Codes and lots: Part Number 682028. Lot numbers: 102034, 103270, 106049, 107034, 108073, 109040, 107034, 110023, 110037, 111023, 203021, 205038, 206055, 207079, 207525, 208110, 208476, 209101, 210095, 211082, 212097, 301139, 301666, 303123, 303616, 305027, 306242, 308059, 309106, 310143, 311160, 312121, 401036, 402022, 403063, 404043, 405079,
Recall started: July 1, 2005
Device type: Catheter, Continuous Flush
Root cause (FDA): Other
What the company told customers: Consignees were notified by letter on 8/22/2005 and told to immediately locate and quarantine all affected product for return to BD. Customer Recall Response Card was to completed and returned. For questions concerning the recall, call 800-453-4538 between 8AM and 5PM MST.
Recall number: Z-0069-06

CRITIFLOW(tm) TA4004 continuous flush catheter

Product: CRITIFLOW(tm) TA4004 continuous flush catheter
Quantity: 20,165 units
Codes and lots: Part Number 682060.Lot numbers: 012485, 101226, 102036, 103011, 103370, 106015, 107041, 108033, 109060, 110004, 111037, 201056, 204002, 205041, 206026, 207062, 208073, 211376, 212407, 301104, 302256, 303085, 303246, 304562, 306211, 306443, 308071, 308169, 308518, 309086, 310124, 311143, 312418, 403315, 404050, 405097, 407055, 407468, 408018.
Recall started: July 1, 2005
Device type: Catheter, Continuous Flush
Root cause (FDA): Other
What the company told customers: Consignees were notified by letter on 8/22/2005 and told to immediately locate and quarantine all affected product for return to BD. Customer Recall Response Card was to completed and returned. For questions concerning the recall, call 800-453-4538 between 8AM and 5PM MST.
Recall number: Z-0070-06

TAKHPQ60R continuous flow catheter

Product: TAKHPQ60R continuous flow catheter.
Quantity: 550 units
Codes and lots: Part Number 682117. Lot numbers 107612, 109012, 110019, 112035, 210060, 212386, 301150.
Recall started: July 1, 2005
Device type: Catheter, Continuous Flush
Root cause (FDA): Other
What the company told customers: Consignees were notified by letter on 8/22/2005 and told to immediately locate and quarantine all affected product for return to BD. Customer Recall Response Card was to completed and returned. For questions concerning the recall, call 800-453-4538 between 8AM and 5PM MST.
Recall number: Z-0071-06

CRITIFLO(tm) TAK0460 continuous flow catheter

Product: CRITIFLO(tm) TAK0460 continuous flow catheter
Quantity: 70 units
Codes and lots: Part number 682118. Lot Numbers 402035, 409152.
Recall started: July 1, 2005
Device type: Catheter, Continuous Flush
Root cause (FDA): Other
What the company told customers: Consignees were notified by letter on 8/22/2005 and told to immediately locate and quarantine all affected product for return to BD. Customer Recall Response Card was to completed and returned. For questions concerning the recall, call 800-453-4538 between 8AM and 5PM MST.
Recall number: Z-0072-06

DT-DL60-1 W/Bifurcated

Product: DT-DL60-1 W/Bifurcated
Quantity: 620 units
Codes and lots: Part Number 682147. Lot numbers 010019, 102055, 105054, 103029, 106054, 107040, 108079, 109045, 110042, 201072, 203025, 207529, 310143, 310147, 311166, 312127, 401042, 401589, 403069.
Recall started: July 1, 2005
Device type: Catheter, Continuous Flush
Root cause (FDA): Other
What the company told customers: Consignees were notified by letter on 8/22/2005 and told to immediately locate and quarantine all affected product for return to BD. Customer Recall Response Card was to completed and returned. For questions concerning the recall, call 800-453-4538 between 8AM and 5PM MST.
Recall number: Z-0073-06

CRITIFLO(tm) flush kit

Product: CRITIFLO(tm) flush kit.
Quantity: 320 units
Codes and lots: Part Number 687198, Lot Numbers 301850, 302267, 303012, 305055.
Recall started: July 1, 2005
Device type: Catheter, Continuous Flush
Root cause (FDA): Other
What the company told customers: Consignees were notified by letter on 8/22/2005 and told to immediately locate and quarantine all affected product for return to BD. Customer Recall Response Card was to completed and returned. For questions concerning the recall, call 800-453-4538 between 8AM and 5PM MST.
Recall number: Z-0074-06

CRITIFLO(tm) FLUSH KIT

Product: CRITIFLO(tm) FLUSH KIT
Quantity: 250 units
Codes and lots: Part Number 687566. Lot Number 302520
Recall started: July 1, 2005
Device type: Catheter, Continuous Flush
Root cause (FDA): Other
What the company told customers: Consignees were notified by letter on 8/22/2005 and told to immediately locate and quarantine all affected product for return to BD. Customer Recall Response Card was to completed and returned. For questions concerning the recall, call 800-453-4538 between 8AM and 5PM MST.
Recall number: Z-0075-06

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0069-06, Z-0070-06, Z-0071-06, Z-0072-06, Z-0073-06, Z-0074-06, Z-0075-06. The agency record governs; check it and the company before acting.

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