FDAFDA · Food and drugs·Recall number Z-2193-2013

* 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.

Published September 18, 2013 · Recall initiated: August 28, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer: Carefusion 2200 Inc
Distributor: 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.
Lot: *** 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 (Expi
Risk classification: Class II
Area (FDA): device
Country: United States

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