FDA Medical devices recall · January 22, 2025

Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK recall

Read the official FDA notice ↗

Product

Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLY; 2) ORTHO PLASTIC MICROVASCULAR PK , Catalog Number: PGVMFFBLZ; 3) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM5; 4) KIT, MAJOR SPINE , Catalog Number: PN33MSOC3; 5) KIT, MAJOR SPINE , Catalog Number: PN33MSOCH; 6) KIT, MAJOR SPINE , Catalog Number: PN33MSOCI; 7) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY6; 8) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY7; 9) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBY8; 10) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYD; 11) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYE; 12) KIT,ORTHO LAMINECTOMY , Catalog Number: PN40LMBYF; 13) KIT, SPINE , Catalog Number: PN40SPMMA; 14) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY1; 15) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY2; 16) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY3; 17) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBY4; 18) KIT, ORTHO LAMINECTOMY , Catalog Number: PO40LMBYC; 19) KIT, ORTHO ANTERIOR CERVICAL , Catalog Number: PO40OAMMA; 20) KIT,WMD SPINE , Catalog Number: PO4ASPWMA; 21) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS951; 22) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS952; 23) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS953; 24) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS954; 25) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS955; 26) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95F; 27) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95G; 28) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95J; 29) KIT, ORP ORTHO ANTERIOR SPINE , Catalog Number: POHDAS95K; 30) KIT,ORP MAJOR SPINE , Catalog Number: POHDFSVCD; 31) KIT,ORP MAJOR SPINE , Catalog Number: POHDFSVCE; 32) KIT, ORTHO SPINE , Catalog Number: POHDOSWC1; 33) KIT, ORTHO SPINE , Catalog Number: POHDOSWC2; 34) KIT, ORTHO SPINE , Catalog Number: POHDOSWC3; 35) KIT, ORTHO SPINE , Catalog Number: POHDOSWC4; 36) KIT, ORTHO SPINE , Catalog Number: POHDOSWC5; 37) KIT, ORTHO SPINE , Catalog Number: POHDOSWC6; 38) KIT, ORTHO SPINE , Catalog Number: POHDOSWC7; 39) KIT, ORTHO SPINE , Catalog Number: POHDOSWCB; 40) KIT, ORTHO SPINE , Catalog Number: POHDOSWCC; 41) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV10; 42) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV11; 43) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV12; 44) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV13; 45) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV14; 46) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV15; 47) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV16; 48) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV17; 49) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSV18; 50) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC3; 51) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC4; 52) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC5; 53) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC6; 54) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC7; 55) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC8; 56) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVC9; 57) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCI; 58) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCJ; 59) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCK; 60) KIT, ORP ORTHO POSTERIOR SPINE , Catalog Number: POHDPSVCM; 61) KIT, SPINE , Catalog Number: POHFSPMH1; 62) KIT, SPINE , Catalog Number: POHFSPMH2; 63) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB10; 64) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB11; 65) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB12; 66) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB13; 67) KIT,ORTHOPLASTIC MICROVASCULAR , Catalog Number: PWVMFFAB14; 68) KIT,ORTHOPLAS

Why was it recalled?

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Catalog Number PGVMFFBLY, UDI/DI 10888439011371 (EA)50888439011379 (CS), Lot Number J34J41 ; Catalog Number PGVMFFBLY, UDI/DI 10888439011371 (EA)50888439011379 (CS), Lot Number J43U77 ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J4952G ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J53W73 ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J4952H ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J6050F ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J74A27 ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J7963D ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J7905F ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J84K02 ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J8692Y ; Catalog Number PGVMFFBLZ, UDI/DI 10888439641936 (EA)50888439641934 (CS), Lot Number J86T82 ; Catalog Number PN23SPAM5, UDI/DI 10195594235604 (EA)50195594235602 (CS), Lot Number 20166041-3014 ; Catalog Number PN23SPAM5, UDI/DI 10195594235604 (EA)50195594235602 (CS), Lot Number 5138318 ; Catalog Number PN33MSOC3, UDI/DI 10197106660881 (EA)50197106660889 (CS), Lot Number 7331471 ; Catalog Number PN33MSOCH, UDI/DI 10197106473498 (EA)50197106473496 (CS), Lot Number 7265882 ; Ca

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-0916-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.