Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-2193-2013

August 28, 2013

Class II

Product summary

Firm
Carefusion 2200 Inc
Event
Event 66123
Status
Terminated
Classification
Class II
Quantity
*** 1) 174,580 units; *** 2) 23,330 units
Official record key
device-enforcement:Z-2193-2013

Official wording

Reason: 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.

Code information: *** 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)

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.