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U.S. Department of Health and Human Services

Class 2 Device Recall 1) Thoracentesis Tray; 2) SafeT Thoracentesis Tray

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 Class 2 Recall
1) Thoracentesis Tray; 2) SafeT Thoracentesis Tray
see related information
Date Posted September 11, 2013
Recall Status1 Open
Recall Number Z-2193-2013
Recall Event ID 66123
Product Classification Needle, Catheter - Product Code GCB
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.
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)
Recalling Firm/
Manufacturer
Carefusion 2200 Inc
75 N Fairway Dr
Vernon Hills, Illinois 60061-1845
For Additional Information Contact Ms. Mindy Faber
847-473-7202
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control
Action 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.
Quantity in Commerce *** 1) 174,580 units; *** 2) 23,330 units
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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