Recalls affecting New Jersey

FDA has not published a risk classification for this recall yet.

Recall #:

87558

Lot/product code:

Assurity Pacemaker Model Number/UDI (GTIN): PM1240 / 05414734507066 PM2240 / 05414734507073 PM2260 / 05414734507097 PM1272 / 05414734509572 PM2272 / 05414734509589 Serial Numbers: 7628828 7629513 7629762 7630106 7630232 7630233 7630235 7630364 7630367 7630369 7630370 7630371 7630372 7630383 7630394 7630397 7630398 7630399 7630400 7630401 7630402 7630403 7630413 7630421 7630428 7630429 7630430 7630431 7630432 7630435 7630442 7630443 7630724 7630725 7630726 7630727 7630729 7630730 7630731 7630732 7630733 7630734 7630736 7630737 7630738 7630739 7630740 7630741 7630742 7630743 7630744 7630745 7630746 7630747 7630748 7630749 7630750 7630751 7630752 7630753 7630754 7630755 7630756 7630757 7630758 7630759 7630760 7630763 7630764 7630765 7630766 7630767 7630768 7630769 7630771 7630772 7630773 7630774 7630776 7630777 7630778 7630779 7630780 7630781 7630782 7630783 7630784 7630785 7630786 7630787 7630788 7630789 7630791 7630792 7630793 7630794 7630795 7630796 7630797 7630798 7630799 7630800 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763… (truncated, 1952273 characters total — see the official FDA record for the full value)

Recalling firm:

St. Jude Medical, Cardian Rhythm Management Division

FDA has not published a risk classification for this recall yet.

Recall #:

87558

Lot/product code:

Endurity Pacemaker Model Number/UDI (GTIN): PM1160 / 05414734507042 PM2160 / 05414734507059 PM1152 / 05414734509763 PM2152 / 05414734509770 PM1172 / 05414734509596 PM2172 / 05414734509602 Serial Numbers: 7649831 7650690 7650710 7650712 7650713 7650715 7650718 7650727 7650742 7650800 7650801 7650802 7650806 7650809 7650811 7650815 7650816 7650817 7650818 7650820 7650821 7650822 7650823 7650824 7650826 7650969 7650971 7650974 7650975 7650976 7650978 7650979 7650980 7650982 7650983 7650984 7650985 7650986 7650987 7650988 7650989 7650990 7650992 7650993 7650994 7650995 7650997 7650998 7651000 7651001 7651002 7651004 7651005 7651006 7651008 7651010 7651011 7651012 7651014 7651015 7651016 7651017 7651018 7651019 7651020 7651021 7651023 7651024 7651027 7651028 7651169 7651171 7651172 7651173 7651174 7651175 7651176 7651177 7651179 7651180 7651181 7651182 7651183 7651185 7651186 7651187 7651188 7651189 7651190 7651191 7651192 7651193 7651194 7651196 7651197 7651198 7651199 7651200 7651201 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77… (truncated, 761010 characters total — see the official FDA record for the full value)

Recalling firm:

St. Jude Medical, Cardian Rhythm Management Division

FDA has not published a risk classification for this recall yet.

Recall #:

87561

Lot/product code:

Lot #: 163878, 192821,191991, 160795 Manufacturer number:O202000

Recalling firm:

Medline Industries Inc

FDA has not published a risk classification for this recall yet.

Recall #:

87703

Lot/product code:

REF: CH3011  UDI: (01) 1 0840619 02396 3 (17) 260101 (30) 50 (10) 5125297  Lot Number: 5125297

Recalling firm:

ICU Medical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

87703

Lot/product code:

REF: CH2000S CH2000S-10 CH2000S-C CH2000SC-10 CH2000SC-5 CH2000SC-5 CH2050  UDI: (01) 1 0840619 033900 (17) 260101 (30) 100 (10) 5125299 (01) 1 0840619 03391 7 (17) 260101 (30) 50 (10) 5142922 (01) 1 0840619 02661 2 (17) 260101 (30) 50 (10) 5125303 (01) 1 0840619 04276 6 (17) 260101 (30) 50 (10) 5142969 (01) 1 0887709 07689 8 (17) 260101 (30) 50 (10) 5125289 (01) 1 0887709 07689 8 (17) 260101 (30) 50 (10) 5142945 (01) 1 0887709 12231 1 (17) 260101 (30) 25 (10) 5125288  Lot Number: 5125299 5142922 5125303 5142969 5125289 5142945 5125288

Recalling firm:

ICU Medical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

87787

Lot/product code:

NDC/UPC: 353885009713 All lots numbers shipped from 2/23/201 to 3/10/2021

Recalling firm:

Cardinal Health Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

87703

Lot/product code:

REF: CH2020  UDI: (01) 1 0840619 08120 8 (17) 251201 (30) 50 (10) 5109274 (01) 1 0840619 08120 8 (17) 260101 (30) 50 (10) 5125259  Lot Number: 5109274 5125259

Recalling firm:

ICU Medical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

87703

Lot/product code:

REF: CL3538   UDI: (01) 1 0887709 07190 9(17) 260101 (30) 50 (10) 5125294  Lot Number: 5125294

Recalling firm:

ICU Medical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

87703

Lot/product code:

REF: CL3011  UDI: (01) 1 0887709 05701 9 (17) 260101 (30) 50 (10) 5125298  Lot Number: 5125298

Recalling firm:

ICU Medical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

87703

Lot/product code:

REF: CH3625  UDI: (01) 1 0887709 08403 9 (17) 260101 (30) 50 (10) 5135758 (01) 1 0887709 08403 9 (17) 260101 (30) 50 (10) 5141854  Lot Number: 5135756 5141854

Recalling firm:

ICU Medical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

87703

Lot/product code:

REF: 20120-01  UDI: (01) 1 0840619 023291 (17) 260101 (30) 100 (10) 5141416  Lot Number: 5141416

Recalling firm:

ICU Medical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

87703

Lot/product code:

REF: 20130-01  UDI: (01) 1 0840619 02338 3 (17) 260101 (30) 50 (10) 5135750 (01) 1 0840619 02338 3 (17) 260101 (30) 50 (10) 5142982  Lot Number: 5135750 5142982

Recalling firm:

ICU Medical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

87703

Lot/product code:

REF: 20124-01  UDI: (01) 1 0887709 07925 7 (17) 260101 (30) 50 (10) 5125197  Lot Number: 5142971

Recalling firm:

ICU Medical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

87703

Lot/product code:

REF: CH3762  UDI: (01) 1 0887709 09833 3 (17) 260101 (30) 50 (10) 5135759  Lot Number: 5135759

Recalling firm:

ICU Medical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

87703

Lot/product code:

REF: CL3946   UDI: (01) 1 0887709 08029 1 (17) 260101 (30) 50 (10) 5142959   Lot Number: 5142959

Recalling firm:

ICU Medical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

87703

Lot/product code:

REF: CH3034  UDI: (01) 1 0840619 02411 3 (17) 260101 (30) 50 (10) 5125305  Lot Number: 5125305

Recalling firm:

ICU Medical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

87703

Lot/product code:

REF: CH3235  UDI: (01) 1 0840619 03403 7 (17) 260101 (30) 50 (10) 5125276  Lot Number: 5125276

Recalling firm:

ICU Medical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

87703

Lot/product code:

REF: 011-H3597  UDI: (01) 1 0840619 06655 1 (17) 260101 (30) 50 (10) 5125225  Lot Number: 5125225

Recalling firm:

ICU Medical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

87703

Lot/product code:

REF: CL3028T  UDI: (01) 1 0887709 09996 5 (17) 260101 (30) 50 (10) 5125199  Lot Number: 5125199

Recalling firm:

ICU Medical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

87703

Lot/product code:

REF: CH3020  UDI: (01) 1 0840619 02400 7 (17) 260101 (30) 50 (10) 5125290   Lot Number: 5125290

Recalling firm:

ICU Medical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

87703

Lot/product code:

REF: 20130-01 CH2000S-PC  UDI: (01) 1 0840619 02338 3 (17) 260101 (30) 50 (10) 5125300 (01) 1 0840619 02756 5 (17) 260101 (30) 50 (10) 5125296  Lot Number: 5125300 5125296

Recalling firm:

ICU Medical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

87703

Lot/product code:

REF: CH2060  UDI: (01) 1 0840619 08123 9 (17) 260101 (30) 50 (10) 5125260  Lot Number: 5125260

Recalling firm:

ICU Medical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

87703

Lot/product code:

REF: CL3960  UDI: (01) 1 0557709 08327 (17) 260101 (30) 50 (10) 5125262  Lot Number: 5125262

Recalling firm:

ICU Medical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

87703

Lot/product code:

REF: 011-H2864-HSR  UDI: (01) 0 0840619 03268 5 (17) 260101 (30) 01 (10) 5142887  Lot Number: 5142887

Recalling firm:

ICU Medical, Inc.

FDA has not published a risk classification for this recall yet.

Recall #:

87703

Lot/product code:

REF: K7040-001  UDI: (01) 1 0887709 036793 (17) 260101 (30) 100 (10) 5135765 (01) 1 0887709 036793 (17) 260101 (30) 100 (10) 5142935  Lot Number: 5135765 5142935

Recalling firm:

ICU Medical, Inc.