FDA-Device2024-04-10Class II
Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256), Product Code 66225; b) ST. KELLY HEMO W/TIPS (SK8039), Product Code 66565; c) STERILE BUTTERFLY PROBE (P837), Product Code 66810; d) STERILE PROBE (PR5), Product Code 66900; e) STERILE NAIL NIPPER, Product Code 67110; f) STERILE FREER SEPTUM ELEVATOR (FE75B), Product Code 67285; g) STERILE 5 1/2" NAIL NIPPER (32195), Product Code 67365; h) STERILE 4 1/4" CUTICLE NIPPER (32908), Product Code 6742
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Sold states
Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Affected count
60075 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256), Product Code 66225; b) ST. KELLY HEMO W/TIPS (SK8039), Product Code 66565; c) STERILE BUTTERFLY PROBE (P837), Product Code 66810; d) STERILE PROBE (PR5), Product Code 66900; e) STERILE NAIL NIPPER, Product Code 67110; f) STERILE FREER SEPTUM ELEVATOR (FE75B), Product Code 67285; g) STERILE 5 1/2" NAIL NIPPER (32195), Product Code 67365; h) STERILE 4 1/4" CUTICLE NIPPER (32908), Product Code 67420; i) STERILE ENGLISH ANVIL NAIL SPLITTER-5", Product Code 67595; j) STERILE UNIVERSAL RING CUTTER(FS02470), Product Code 67780; k) STERILE FINGER NAIL CLIPPER, Product Code 589784ST; l) BILLEAU EAR LOOP 4MM 6" LARGE, Product Code BEL46ST; m) PROBE WITH EYE, Product Code DYND04011; n) STERILE 9" MAYO SCISSOR (ST150), Product Code I67350; o) STRL ROCHESTER OCHSNER SATIN 7 1/4", Product Code I67695; p) CMP* NAIL NIPPER ANGLED 4.5, Product Code I67980; q) STERILE BILLEAU EAR LOOP 3MM, Product Code I67995; r) ST. ALLIGATOR FORCEP, POINTED, MICRO P/S, Product Code I68020; s) MOSQUITO HEMOSTAT FINE TIP, Product Code I68190; t) STERILE VAS DEFERENS CLAMP (VDC100S), Product Code I68200; u) LILLIE EAR HOOK, 7" STERILE (P/S), Product Code I68305; v) ST FOX DERMAL CURE, 4MM, 5 1/2 (32922), Product Code I68360; w) STERILE SKIN HOOK - SHARP (SH25754), Product Code I68415; x) ST. EYE LID SPECULUM WIRE ADULT (ES500P), Product Code I68460; y) STERILE NAIL RASP DOUBLE ENDED (NR100), Product Code I68500; z) ST. SCLERAL DEPRESSOR 5.5" (SD500), Product Code I68515; aa) STERILE NAIL SPLITTING FORCEP 4" (NS400), Product Code I68600; bb) STERILE 12" PROBE W/ EYE, Product Code I68840; cc) COMEDONE EXTRACTOR, STERILE (P/S), Product Code I86540; dd) STERILE SPATULA & PACKER, Product Code I86695; ee) STERILE - PHLBCTMY HOOK CRCHT STYL 6, Product Code I86875; ff) STERILE FREER SEPTUM ELEVATOR (FE75B), Product Code P-67285 MEDLINE PROBE WITH EYE, Product Code DYND04011
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1441-2024Don't want to check this manually?
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