| Class 2 Device Recall Medline |  |
Date Initiated by Firm | April 08, 2024 |
Date Posted | August 28, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2747-2024 |
Recall Event ID |
94581 |
Product Classification |
Ear, nose, and throat surgical tray - Product Code OGR
|
Product | Medline procedural kits labeled as:
1) TYMPANOPLASTY , Pack Number CDS980203S;
2) MAJOR EAR , Pack Number CDS982016T;
3) MAJOR EAR PACK, Pack Number CMPJ01846O;
4) EAR PACK, Pack Number CMPJ05884J;
5) MZ EAR PACK , Pack Number CMPJ09860D;
6) KIT MAJOR EAR CHRG, Pack Number CMPJ09914C;
7) ENT PACK, Pack Number CMPJ13389A;
8) ENT PACK, Pack Number CMPJ13389B;
9) ENT PACK, Pack Number CMPJ13389C;
10) DR LIN EAR PACK , Pack Number CMPJ13509 ;
11) TYMPANOPLASTY PACK, Pack Number CMPJ21114O;
12) EAR PACK-LF , Pack Number DYNJ0425965G ;
13) EAR PACK-LF , Pack Number DYNJ0774664K ;
14) HL EAR PACK , Pack Number DYNJ40560B;
15) HL EAR PACK , Pack Number DYNJ40560BH;
16) EAR PACK, Pack Number DYNJ44134C;
17) EAR PACK, Pack Number DYNJ44134D;
18) EAR PACK, Pack Number DYNJ44134F;
19) MINOR ENT PACK, Pack Number DYNJ45577A;
20) ENT PACK, Pack Number DYNJ48595 ;
21) MH NASAL, Pack Number DYNJ49888I;
22) MH NASAL, Pack Number DYNJ49888J;
23) MIDDLE EAR OR , Pack Number DYNJ52583G;
24) MIDDLE EAR OR , Pack Number DYNJ52583J;
25) MIDDLE EAR OR , Pack Number DYNJ52583L;
26) ***, Pack Number DYNJ52583M;
27) GLENNON HEAD AND NECK PACK-LF , Pack Number DYNJ57200A;
28) MIDDLE EAR PACK , Pack Number DYNJ65935A;
29) ENT PACK, Pack Number DYNJ66039B;
30) FACIAL PACK , Pack Number DYNJ82177B;
31) FACIAL PACK , Pack Number DYNJ82177BH;
32) EAR CUSTOM PACK , Pack Number DYNJ82564 ;
33) ***, Pack Number DYNJ86113 ;
34) EAR , Pack Number DYNJ901779J;
35) MZ EAR CDS, Pack Number DYNJ905642D;
36) PACK MAJOR EAR CHRG , Pack Number DYNJ905694C;
37) ENT , Pack Number DYNJ909128A;
38) ENT , Pack Number DYNJ909128C;
39) ENT , Pack Number DYNJ909128D;
40) ***, Pack Number DYNJ909128D;
41) DR LIN EAR, Pack Number DYNJ909251;
42) T AND A , Pack Number DYNJ909941;
43) ***, Pack Number DYNJ909941 |
Code Information |
CDS980203S, Lot Numbers:23DBT154;
CDS980203S, Lot Numbers:23HBT797;
CDS980203S, Lot Numbers:23JBM122;
CDS980203S, Lot Numbers:23LBC884;
CDS980203S, Lot Numbers:21CBW683;
CDS982016T, Lot Numbers:22GBM951;
CDS982016T, Lot Numbers:22GBO165;
CDS982016T, Lot Numbers:22HBS644;
CMPJ01846O, Lot Numbers:21LBQ988;
CMPJ01846O, Lot Numbers:22FBV101;
CMPJ05884J, Lot Numbers:21KBO037;
CMPJ05884J, Lot Numbers:21KBU691;
CMPJ05884J, Lot Numbers:21LBH778;
CMPJ05884J, Lot Numbers:22IBG052;
CMPJ05884J, Lot Numbers:22JBN865;
CMPJ09860D, Lot Numbers:23KMB793;
CMPJ09914C, Lot Numbers:23IDA209;
CMPJ13389A, Lot Numbers:23CBL552;
CMPJ13389B, Lot Numbers:23IBC818;
CMPJ13389C, Lot Numbers:23KBU012;
CMPJ13389C, Lot Numbers:23LBF106;
CMPJ13389C, Lot Numbers:24ABD504;
CMPJ13389C, Lot Numbers:24ABY610;
CMPJ13389C, Lot Numbers:24BBV889;
CMPJ13509, Lot Numbers:23IBF142;
CMPJ21114O, Lot Numbers:23BBQ474;
CMPJ21114O, Lot Numbers:23HBG033;
CMPJ21114O, Lot Numbers:23IBV766;
CMPJ21114O, Lot Numbers:23JBM292;
CMPJ21114O, Lot Numbers:23KBK531;
CMPJ21114O, Lot Numbers:21BBJ985;
DYNJ0425965G, Lot Numbers:23GMH984;
DYNJ0774664K, Lot Numbers:23HBP871;
DYNJ40560B, Lot Numbers:23HBF219;
DYNJ40560BH , Lot Numbers:23HBF219;
DYNJ44134C, Lot Numbers:22JBQ075;
DYNJ44134D, Lot Numbers:23BBK410;
DYNJ44134D, Lot Numbers:23CBS145;
DYNJ44134F, Lot Numbers:23EBC602;
DYNJ44134F, Lot Numbers:23GBV482;
DYNJ44134F, Lot Numbers:23JBP398;
DYNJ44134F, Lot Numbers:23KBN024;
DYNJ44134F, Lot Numbers:24ABC027;
DYNJ45577A, Lot Numbers:21KBL221;
DYNJ45577A, Lot Numbers:21KBT524;
DYNJ48595, Lot Numbers:24BBO457;
DYNJ49888I, Lot Numbers:22AMG372;
DYNJ49888I, Lot Numbers:22KMD386;
DYNJ49888J, Lot Numbers:24AMG698;
DYNJ52583G, Lot Numbers:21HBC324;
DYNJ52583G, Lot Numbers:21KBM269;
DYNJ52583J, Lot Numbers:21LBN305;
DYNJ52583L, Lot Numbers:22DBB163;
DYNJ52583L, Lot Numbers:22FBF207;
DYNJ52583L, Lot Numbers:22HMF439;
DYNJ52583L, Lot Numbers:22JMC614;
DYNJ52583L, Lot Numbers:23JMF994;
DYNJ52583M, Lot Numbers:24CMF962;
DYNJ57200A, Lot Numbers:23HBN488;
DYNJ65935A, Lot Numbers:23HBR355;
DYNJ65935A, Lot Numbers:23HBT376;
DYNJ66039B, Lot Numbers:23GBQ016;
DYNJ82177B, Lot Numbers:23KMB826;
DYNJ82177BH , Lot Numbers:23KMB826;
DYNJ82564, Lot Numbers:23GBV431;
DYNJ86113, Lot Numbers:24CBE092;
DYNJ901779J , Lot Numbers:21KBY716;
DYNJ901779J , Lot Numbers:21LBS995;
DYNJ901779J , Lot Numbers:21LBV102;
DYNJ901779J , Lot Numbers:22IBS613;
DYNJ901779J , Lot Numbers:22JBY312;
DYNJ901779J , Lot Numbers:22JBY313;
DYNJ901779J , Lot Numbers:23BBB017;
DYNJ905642D , Lot Numbers:23KMH482;
DYNJ905694C , Lot Numbers:23IDB849;
DYNJ909128A , Lot Numbers:23DBD851;
DYNJ909128C , Lot Numbers:23JBO251;
DYNJ909128D , Lot Numbers:23LBM416;
DYNJ909128D , Lot Numbers:23LBQ695;
DYNJ909128D , Lot Numbers:24ABR742;
DYNJ909128D , Lot Numbers:24BBM816;
DYNJ909128D , Lot Numbers:24CBK211;
DYNJ909251, Lot Numbers:23IBT842;
DYNJ909251, Lot Numbers:23IBT854;
DYNJ909251, Lot Numbers:23IBV449;
DYNJ909251, Lot Numbers:23JBT806;
DYNJ909941, Lot Numbers:23JBH984;
DYNJ909941, Lot Numbers:24ABD605;
DYNJ909941, Lot Numbers:24ABD695;
DYNJ909941, Lot Numbers:24ABT569;
DYNJ909941, Lot Numbers:24CBK472
|
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 | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods. |
Distribution | Worldwide |
Total Product Life Cycle | TPLC Device Report |
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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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