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U.S. Department of Health and Human Services

Class 2 Device Recall XStream Irrigation System

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 Class 2 Device Recall XStream Irrigation Systemsee related information
Date Initiated by FirmJune 27, 2022
Create DateJuly 22, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1457-2022
Recall Event ID 90555
510(K)NumberK003790 
Product Classification Laparoscope, general & plastic surgery - Product Code GCJ
ProductX-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)
Code Information UDI-DI: 00801741010118 All lots Catalog No. 5551000: 41HLNX03 41ILNX01 41ILNY01 41ILNY03 ST5313 41ILNX02 41LNX02 41HLN103 ST6533 41JLNX02 41JLNX01 41KLNX01 ST6558 ST5304 ST7450 41AMNB36 41LLNX03 ST5302 ST5303 ST7527 ST7524 41LLNX01 41AMNX01 41bmnx01 41LLNX02 41bmn01 ST5306 41clat29 ST5308 ST9445 41KLNX02 ST9366 ST9367 41BMMB36 ST8144 ST8145 ST8267 41AMNX03 41JLNZ02 41EMNX03 ST8313 41EMNX02 41AMXN01 41EMNX01 ST8826 ST8789 ST9925 43EMNX03 SN#J0405 SN#DJ0405 DJ0479 DJ0463 DJ0451 DJ0517 DJ0476 DJ0438 DJ0465 DJ0467 DJ0518 EB1032EA0776EA0782 DJO366 DJO045 DJO359 DJ0366 DJ0045 DJ0359 DJ0765 DL0625 DL0694 DL0690 DK0591 4BMNX01 41HMNX02 41IMNX01 41INMX01 ST10500 ST10165 EH2070V3 EH2008V3 EH2007V3 EH2025V3 EH2004V3 41IMNX02 ST8668 EH2010V3 DI0282 41JMNX01 41GMNX01 41GMNOX02 41GMNX02 41HMNX01 EI2145V3 EI2130V3 EI2147V3 EI2146V3 EI2163V3 ST10888 ST11290 EB0991 EG1652V3 ST11141 41EMN103 416mnx02 EG1579V3 EG1561V3 EG1605V3 EG1562V3 EG1674V3 DK0590 DJ0380 DJ0393 ST10896 DL0640 DL0664 41GMNZ02 41GMNX03 41EMXX03 41GLNX02 EG1623V3 EG1772V3 EG1625V3 DJ0345 EB0916V3 EB0950V3 EB0965V3 EB0966V3 EE1305V3 EE1446V3 41BMMX01 ee1170v3 ee1174v3 ee1199v3 ee1210v3 41EMX01 eb0935v3 eb0989v3 eb0995v3 eb1017v3 41EMXN01 EE1327V3 EE1303V3 EE1421V3 ee1167v3 sn ee1204v3 EA0781 DG0078V3 EI2288V3 EE1171V3 EE1202V3 EE1183V3 EE1189V3 EE1207V3 EE1212V3 ee1180v3 ee1187v3 ee1208v3 EG1504V3 DK0536V3 EI2277V3 EI2296V3 ST11995 EB1161 EE1344 ST13037 41MNX001 41mnxx01 41mnx01 ST13127 41hmx01 ST13559 41anmb40 41EMNX01 41EMNX03 41BMNX01 STEG1737V3 EG1800V3 EG1737V3 EE1237V3 EE1283V3 STEB0938V3 EB1034V3 EB0938V3 DL0623 EH1837V3 EE1279V3 EA0780 SE1368V3 EB1079V3 EB1115V3 EE1180 EE1442 EE1318 EE1383 1402V3 EE1385 EE1402V3 EE1442V3 EE1318V3 EE1383V3 EG1779V3 EH1992V3 DH00207V3 DH0207V3 ST16676 ST16596 ST16773 DJ0495VS DJ0467VS ST17314 EA0819V3 EG1599V3 EG1525V3 41aonx01 EE1172V3 EE1192V3 41aonxol 41gonx01 41aonx02 ga2454v3 GA2437V3 41donx01 STE4333 41konx01 STE5063 DJ0480V3 STE5188 DK0543V3 GA2388V3 STE5640 41epnx01 41fpnx01 STE7955 STE7845 STE8761 SN#2737V3 SN#2745V3 SN#2748V3 SN#HE2677V3 SN#HE2737V3 SN#HE2745V3 SN#HE2748V3 41kpnx01 STE9906 SN#HK2903V3 SN#HK2897V3 SN#HK2894V3 SN#HK2938V3 SN#HK2943V3 daqbnx01 SN#HK2922V3 SN#HK2928V3 SN#HK2910V3 SN#DAQB3007V3 lot#daqbnx01 daqcnx01 daqhnx01 daqhnx02 daqknx01 daqk3336v3 daqk3340v3 daqk3343v3 daranx01 darcnx01 darjnx01 RJ3597V3 dasanx01 dasenx01 dasknx01 datanx01 datenx01 DATGNX01 datjnx01 datlnx01 daubnx01 daucnx01 dauenx01 DAUE4328V3 DAUE4320V3 DAUE4347V3 DAUE4365V3 DAUE4353V3 DAUE4325V3 DAUE4344V3 DAUE4338V3 DAUE4364V3 DAUE4341V3 DAUE4330V3 DAUE4369V3 DAUE4357V3 DAUE4336V3 darj3666v3 darc3532v3 dauc4283v3 daqk3270v3 dara3382v3 dauc4277v3 dauhnx01 DAUJNX01 daulnx01 dava4754v3 dava4758v3 dava4763v3 dava4768v3 dava4755v3 dava4766v3 dava4769v3 dava4751v3 dava4721v3 dava4720v3 dava4722v3 dava4767v3 dava4743v3 dava4744v3 dava4764v3 dava4723v3 dava4759v3 dava4724v3 dava4725v3 dava4726v3 dava4727v3 dava4728v3 dava4729v3 dava4730v3 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DACT6575 DACT6581 DACT6587 DACQ6517 DACT6584 DACT6586 DACT6574 DACT6549 DACT6561 DACT6593 DACQ6541 DACT6560 DACT6556 DACT6562 DACT6548 DACT6580 DACT6565 DACT6576 DACT6595 DACQ6530 DACQ6539 DACT6553 DACT6569 DACT6570 DACT6573 DACW6602 DACW6614 DACW6619 DACT6588 DACT6594 DACT6577 DACW6621 DACW6596 DACT6558 DACW6599 DACW6615 DACW6618 DACW6632 DACW6598 DACW6608 DACW6627 DACZ6650 DACZ6652 DACZ6648 DACZ6646 DACZ6673 DACZ6656 DACZ6651 DACZ6653 DACZ6678 DACZ6668 DACZ6661 DACZ6662 DACZ6676 DACZ6677 DACZ6692 DACZ6660 DACZ6672 DACZ6680 DACZ6657 DACZ6674 DACZ6683 DACZ6647 DACZ6658 DACZ6667 DACZ6670 DACZ6675 DACZ6681 DACZ6684 DACZ6664 DACZ6695 DACZ6669 DACZ6649 DACZ6665 DACZ6686 DACZ6693 DACZ6694 DACZ6688 DACZ6659 DACZ6663 DACZ6671 DACZ6682 DACZ6687 DACZ6689 DACZ6691 DACZ6690 DACW6625 DACZ6655 DACW6617 DACW6603 DACW6628 DACW6630 DACW6622 DACW6634 DACW6638 DACW6601 DACW6606 DACW6623 DACT6555 DACZ6679 DACW6609 DACW6624 DACW6629 DACW6639 DACW6641 DACW6626 DACW6620 DACW6604 DACW6613 DACW6633 DACW6616 DACW6640 DACW6636 DACW6637 DACW6642 DACW6600 DACW6612 DACW6631 DACW6645 DACW6635 DACW6605 DACW6597 DACW6643 DADQ6703 DADQ6699 DADQ6704 DADQ6715 DADQ6700 DADQ6710 DADQ6716 DADQ6720 DADQ6721 DADQ6731 DADQ6736 DADQ6743 DADQ6711 DADQ6737 DADQ6696 DADQ6728 DADQ6723 DADQ6701 DADQ6724 DADQ6741 DADQ6714 DADQ6718 DADQ6722 DADQ6732 DADQ6733 DADQ6734 DADQ6698 DADQ6702 DADQ6712 DADQ6717 DADQ6744 DADQ6706 DADQ6708 DADQ6740 DADQ6719 DADQ6729 DADQ6697 DADQ6705 DADQ6709 DADQ6726 DADQ6735 DADQ6738 DADQ6739 DADQ6742 DADQ6745 DADQ6707 DADQ6713 DADQ6730 DADT6752 DADT6767 DADT6759 DADT6772 DADT6755 DADT6758 DADT6762 DADT6764 DADT6760 DADT6771 DADZ6853 DADT6756 DADT6754 DADT6770 DADT6779 DADT6783 DADT6782 DADT6746 DADT6780 DADT6787 DADT6747 DADT6750 DADT6751 DADT6757 DADT6761 DADT6765 DADT6766 DADT6768 DADT6769 DADT6773 DADT6775 DADT6776 DADT6777 DADT6778 DADT6781 DADT6784 DADT6785 DADT6786 DADT6788 DADT6789 DADT6790 DADT6793 DADT6794 DADT6795 DADT6774 DADT6792 DADZ6879 DADT6791 DADZ6889 DADZ6886 DADZ6846 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Recalling Firm/
Manufacturer
Davol, Inc.
100 Crossings Blvd
Warwick RI 02886-2850
For Additional Information ContactNorth American Regional Complaint Center
844-823-5433
Manufacturer Reason
for Recall
The device may potentially cause a fire, leading to a safety risk.
FDA Determined
Cause 2
Under Investigation by firm
ActionOn June 27, 2022, the firm notified customers of the recall through Urgent Medical Device Recall letters. Customers were instructed to immediately identify and destroy all remaining product in your possession. BD will issue credit to customers who purchased the product from BD. If the customer purchased the product from a Distributor, contact your distributor for further instructions and credit resolution. If you have further questions about this recall, contact the firm: Phone: 1-844-8BD- LIFE (1-844-823-5433) Say Recall when prompted M-F 8am - 5pm CT Email: productcomplaints@bd.com
Quantity in Commerce9420 (9337 in US; 83 OUS)
DistributionWorldwide distribution - US Nationwide and the countries of Canada and Chile.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GCJ
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