—#121524

Product

*** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA; *** 2) Cat. 4341BSDF; Qty. 10; Safe-T Thoracentesis Tray; With Catheter and Sharps Injury Protection; Drug Free; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA. Indicated for specimen retrieval and therapeutic drainage of the pleural cavity.

FDA product code: GCB — Needle, Catheter
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: *** 1) Product Code: 4341B; Lots: 554361 (Expires 11/30/15); 550463 (Expires 11/30/15); 548675 (Expires 11/30/15); 545891 (Expires 10/31/15); 544746 (Expires 10/31/15); 543978 (Expires 10/31/15); 542297 (Expires 10/31/15); 541063 (Expires 10/31/15); 539859 (Expires 10/31/15); 539470 (Expires 10/31/15); 537723 (Expires 9/30/15); 536497 (Expires 9/30/15); 535600 (Expires 9/30/15); 534616 (Expires 9/30/15); 532917 (Expires 8/31/15); 531869 (Expires 8/31/15); 530729 (Expires 8/31/15); 528789 (Expires 8/31/15); 526724 (Expires 8/31/15); 525767 (Expires 8/31/15); 523275 (Expires 8/31/15); 522256 (Expires 8/31/15); 517247 (Expires 7/31/15); 514103 (Expires 7/31/15); 512953 (Expires 7/31/15); 509413 (Expires 5/31/15); 508928 (Expires 5/31/15); 505191 (Expires 5/31/15); 504328 (Expires 4/30/15); 499957 (Expires 4/30/15); 498168 (Expires 4/30/15); 495057 (Expires 3/31/15), 492933 (Expires 3/31/15); 487660 (Expires 2/28/15); 486920 (Expires 2/28/15); 483377 (Expires 11/30/14); 481000 (Expires 11/30/14); 478361 (Expires 11/30/14); 476883 (Expires 11/30/14); 474403 (Expires 10/31/14); 471330 (Expires 10/31/14); 469597 (Expires 10/31/14); 469561 (Expires 10/31/14); 467093 (Expires 10/31/14); 464366 (Expires 10/31/14); 463156 (Expires 8/31/14); 461311 (Expires 8/31/14); 458579 (Expires 8/31/14); 456606 (Expires 8/31/14); 453734 (Expires 8/31/14); 450541 (Expires 8/31/14); 450540 (Expires 8/31/14); 446817 (Expires 8/31/14); 444048 (Expires 8/31/14); 440805 (Expires 8/31/14); 439236 (Expires 8/31/14); 436820 (Expires 8/31/14) ;433808 (Expires 7/31/14); 429003 (Expires 7/31/14); 427075 (Expires 7/31/14); 424115 (Expires 7/31/14); 420673 (Expires 6/30/14); 419197 (Expires 6/30/14); 417436 (Expires 6/30/14); 413285 (Expires 6/30/14); 411301 (Expires 6/30/14); 408552 (Expires 7/31/14); 405227 (Expires 6/30/14); 403653 (Expires 6/30/14); 400855 (Expires 6/30/14); 399197 (Expires 6/30/14); 389066 (Expires 5/31/14); 387167 (Expires 5/31/14); 382554 (Expires 5/31/14); 380046 (Expires 4/30/14); 377477 (Expires 4/30/14); 375047 (Expires 4/30/14); 372900 (Expires 4/30/04); 370763 (Expires 4/30/14); 370204 (Expires 3/31/14); 368133 (Expires 3/31/14); 366017 (Expires 3/31/14); 363544 (Expires 3/31/14); 362824 (Expires 3/31/14); 362000 (Expires 2/28/14); 359063 (Expires 2/28/14); 357349 (Expires 2/28/14); 352522 (Expires 1/31/14); 350387 (Expires 1/31/14); 348043 (Expires 1/31/14); 347360 (Expires 1/31/14); 343651 (Expires 10/31/14); 341316 (Expires 1/31/14); 339958 (Expires 1/31/14); 335395 (Expires 12/31/13); 333550 (Expires 12/31/13); 330580 (Expires 11/30/13); 327592 (Expires 11/30/13); 326052 (Expires 10/31/13); 322688 (Expires 10/31/13); 320605 (Expires 10/31/13); 316289 (Expires 9/30/13); 313891 (Expires 9/30/13); 312365 (Expires 9/30/13); 308400 (Expires 9/30/13); L1B129 (Expires 8/31/13); L1B177 (Expires 8/31/13); L1B215 (Expires 10/31/13); L1B311 (Expires 10/31/13); L1C150 (Expires 12/31/13); L1C190 (Expires 12/31/13; L1C273 (Expires 8/31/13); L1C376 (Expires 8/31/13); *** 2) Product Code: 4341BSDF; Lots: 548682 (Expires 2/28/18); 542824 (Expires 2/28/18); 528896 (Expires 12/31/17); 523596 (Expires 12/31/17); 522262 (Expires 12/31/17); 511661 (Expires 10/31/17); 486156 (Expires 8/31/17); 485085 (Expires 8/31/17); 469770 (Expires 6/30/17); 456730 (Expires 5/31/17); 437220 (Expires 3/31/17); 435599 (Expires 3/31/17); 363941 (Expires 8/31/16) 362922 (Expires 8/31/16); 354615 (Expires 7/31/16); 349218 (Expires 7/31/16); 347700 (Expires 7/31/16); 347346 (Expires 6/30/16); L1B185 (Expires 2/28/16); L1B321 (Expires 3/31/16); L1C201 (Expires 3/31/16); L0A238 (Expires 1/13/15); L0C212 (Expires 3/31/15); L0D150 (Expires 4/30/15); L0E143 (Expires 5/31/13); L0J242 (Expires 7/31/15); L0J274 (Expires 8/31/15); L0K270 (Expires 9/30/15); L0L264 (Expires 10/31/15); L0P117 (Expires 11/30/15); L0P126 (Expires 11/30/15); L9A294 (Expires 1/31/14); L9C267 (Expires 3/31/14); L9D320 (Expires 4/30/14); L9E238 (Expires 5/31/14); L9H237 (Expires 6/30/14); L9J212 (Expires 7/31/14); L9K261 (Expires 9/30/14); L9P191 (Expires 12/31/14); L8K258 (Expires 8/31/13); L8L229 (Expires 9/30/13); L8S323 (Expires 12/31/13)

Why it was recalled

Catheters included in Thoracentesis Tray and Safe-T Thoracentesis Tray - Drug Free may occlude, preventing drainage of excessive fluid from the pleural cavity leading to a potential delay in the medical procedure and potentially serious patient complications.

Root cause (FDA determination)

Process change control

Action the firm took

Recall notification letters dated 8/27/13 were distributed via courier to direct accounts. Consignees were/are requested to confirm receipt of the notification, examine their inventory for the recalled products and to destroy the products. After the products are destroyed, the consignees are requested to submit a completed response form to CareFusion for replacement with functional devices. Consignees who cannot destroy the affected products are requested to contact CareFusion for additional information.

Recalling firm

Firm: Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MD, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV and Puerto Rico, and the country of Iceland.

Timeline

Recall initiated: 2013-08-28
Posted by FDA: 2013-09-11
Terminated: 2015-06-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #121524. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.