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U.S. Department of Health and Human Services

Class 2 Device Recall Centurion

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  Class 2 Device Recall Centurion see related information
Date Initiated by Firm February 23, 2024
Date Posted March 29, 2024
Recall Status1 Open3, Classified
Recall Number Z-1441-2024
Recall Event ID 94136
Product Classification Instrument, surgical, disposable - Product Code KDC
Product 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
Code Information a) 66225, UDI/DI 60653160018327 (case) 00653160018325 (each), Lot Numbers: 2023070390; b) 66565, UDI/DI 20653160059865 (case) 00653160059861 (each), Lot Numbers: 2023022090; c) 66810, UDI/DI 60653160038547 (case) 00653160038545 (each), Lot Numbers: 2023042490; d) 66900, UDI/DI 60653160038868 (case) 00653160038866 (each), Lot Numbers: 2023030890, 2023100390, 2023111090; e) 67110, UDI/DI 50653160049751 (case) 00653160049756 (each), Lot Numbers: 2023042490, 2023051590, 2023110290; f) 67285, UDI/DI 50653160089139 (case) 00653160089134 (each), Lot Numbers: 2023081490, 2023101190; g) 67365, UDI/DI 10653160115120 (case) 00653160115123 (each), Lot Numbers: 2023040390, 2023090790, 2023101790, 2023110890; h) 67420, UDI/DI 10653160123491 (case) 00653160123494 (each), Lot Numbers: 2023100590; i) 67595, UDI/DI 10653160184553 (case) 00653160184556 (each), Lot Numbers: 2023032890, 2023101390; j) 67780, UDI/DI 10653160196662 (case) 00653160196665 (each), Lot Numbers: 2023071290; k) 589784ST, UDI/DI 40653160130681 (case) 00653160130683 (each), Lot Numbers: 2023020990, 2023030790, 2023042890; l) BEL46ST, UDI/DI 10653160227168 (case) 00653160227161 (each), Lot Numbers: 2023101890; m) DYND04011, UDI/DI 40884389097800 (case) 10884389097809 (each), Lot Numbers: 2023102090; n) I67350, UDI/DI 00653160286847 (case) 10653160286844 (each), Lot Numbers: 2023031390, 2023111790; o) I67695, UDI/DI 00653160263060 (case) 10653160263067 (each), Lot Numbers: 2023110290 (not distributed); p) I67980, UDI/DI 10653160224815 (case) 00653160224818 (each), Lot Numbers: 2023031690; q) I67995, UDI/DI 10653160227656 (case) 00653160227659 (each), Lot Numbers: 2023042690, 2023101790, 2023111090; r) I68020, UDI/DI 10653160228349 (case) 00653160228342 (each), Lot Numbers: 2023092990, 2023111590; s) I68190, UDI/DI 00653160263299 (case) 10653160263296 (each), Lot Numbers: 2023041390, 2023090790; t) I68200, UDI/DI 00653160263077 (case) 10653160263074 (each), Lot Numbers: 2023101890; u) I68305, UDI/DI 00653160277647 (case) 10653160277644 (each), Lot Numbers: 2023072090; v) I68360, UDI/DI 00653160280852 (case) 10653160280859 (each), Lot Numbers: 2023021490; w) I68415, UDI/DI 00653160286946 (case) 10653160286943 (each), Lot Numbers: 2023111790; x) I68460, UDI/DI 00653160289886 (case) 10653160289883 (each), Lot Numbers: 2023030990, 2023060690, 2023100390; y) I68500, UDI/DI 00653160293555 (case) 10653160293552 (each), Lot Numbers: 2023061490, 2023111390; z) I68515, UDI/DI 00653160293548 (case) 10653160293545 (each), Lot Numbers: 2023061290; aa) I68600, UDI/DI 00653160308334 (case) 10653160308331 (each), Lot Numbers: 2023042790; bb) I68840, UDI/DI 00653160331578 (case) 10653160331575 (each), Lot Numbers: 2023021690, 2023050890, 2023091890; cc) I86540, UDI/DI 00653160270907 (case) 10653160270904 (each), Lot Numbers: 2023041390; dd) I86695, UDI/DI 00653160291834 (case) 10653160291831 (each), Lot Numbers: 2023042090; ee) I86875, UDI/DI 00653160359190 (case) 10653160359197 (each), Lot Numbers: 2023032790; ff) P-67285, UDI/DI 50653160089139 (case) 00653160089134 (each), Lot Numbers: 2023120590 MEDLINE: UDI/DI 40884389097800 (case), 10884389097809 (each), Lot Numbers: 2023102090
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Karin Johnson
886-359-1704
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Process control
Action Medline Industries, LP, issued a Medical Device Recall notice to its consignees on 02/27/2024 via email and USPS First Class mail. The notice explained the problem with the devices, risk, and requested that the products be destroyed at the consignee. Distributors were directed to notify their customers.
Quantity in Commerce 60075 units
Distribution Worldwide distribution - US Nationwide and the countries of Panama, Canada.
Total Product Life Cycle TPLC 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.
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