| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | April 08, 2024 |
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| Date Posted | September 06, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-3028-2024 |
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| Recall Event ID |
94583 |
| Product Classification |
Laceration tray - Product Code PKD
|
| Product | Medline Convenience kits labeled as:
1) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200A ;
2) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200AH;
3) CUST CHEST TUBE INSERTION X , Pack Number DYNDA2415B ;
4) LACERATION TRAY , Pack Number DYNDL1495A ;
5) LACERATION TRAY , Pack Number DYNDL1495AH;
6) LACERATION TRAY , Pack Number DYNDL1807B ;
7) LACERATION WITH INSTMTS TRAY, Pack Number DYNDL1963;
8) LACERATION WITH INSTMTS TRAY, Pack Number DYNDL1963H ;
9) LACERATION TRAY , Pack Number DYNDL1965A ;
10) STERILE RESUTURE PACK, Pack Number DYNDL1980A;
11) STERILE RESUTURE PACK, Pack Number DYNDL1980AH;
12) LACERATION TRAY , Pack Number DYNDL1981;
13) LACERATION TRAY , Pack Number DYNDL1985;
14) SUTURE TRAY , Pack Number DYNDL1986;
15) FGH FLOOR KIT , Pack Number DYNDL1989;
16) LACERATION KIT, Pack Number DYNDL1991;
17) LACERATION KIT, Pack Number DYNDL1992;
18) LACERATION KIT, Pack Number DYNDL1992H ;
19) ER LACERATION TRAY, Pack Number DYNDL1993;
20) LACERATION TRAY , Pack Number DYNDL1994;
21) CLOSURE PACK-LF , Pack Number DYNJ0807503N ;
22) CLOSING BUNDLE, Pack Number DYNJ52157I ;
23) PREMIUM CLOSUREPLUS PACK, Pack Number DYNJ54326A ;
24) ABD CLOSURE PACK, Pack Number DYNJ56987C ;
25) CLOSING PACK, Pack Number DYNJ57577A ;
26) SURGERY CLOSING KIT , Pack Number DYNJ67429B ;
27) CLOSING PACK, Pack Number DYNJ68267B ;
28) MICRODISECTOMY PACK , Pack Number DYNJ80585B ;
29) PREP TRAY , Pack Number DYNJRA1583D;
30) NECESSAIRES A POINT DE SUTURES, Pack Number M101498;
31) MAJOR LACERATION PACK-LF, Pack Number PHS751688G;
32) IR SUTURE PACK-LF , Pack Number PHS863717D ;
33) FINE LACERATION KIT , Pack Number SUT17215A;
34) MINOR LACERATION TRAY , Pack Number SUT18200 ;
35) LACERATION TRAY, Pack Number SUT20285A;
36) LACERATION TRAY W/ LIDOCAINE, Pack Number SUT20595A;
37) SNAG FREE LACERATION TRAY, Pack Number SUT21665;
38) LACERATION TRAY , Pack Number SUT21710 ;
39) LACERATION REPAIR TRAY, Pack Number SUT21780 ;
40) SNAG FREE LACERATION TRAY , Pack Number SUT21825 |
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| Code Information |
DYKMBNDL200A , Lot Number 22KBD675 ;
DYKMBNDL200A , Lot Number 23KBA331 ;
DYKMBNDL200AH, Lot Number 22KBD675 ;
DYKMBNDL200AH, Lot Number 23KBA331 ;
DYNDA2415B , Lot Number 23JLA114 ;
DYNDA2415B , Lot Number 24BLB045 ;
DYNDL1495A , Lot Number 22LBJ768 ;
DYNDL1495A , Lot Number 23ABG899 ;
DYNDL1495A , Lot Number 23CBF146 ;
DYNDL1495A , Lot Number 23DBO301 ;
DYNDL1495A , Lot Number 23EBC524 ;
DYNDL1495A , Lot Number 23EBR564 ;
DYNDL1495A , Lot Number 23GBC601 ;
DYNDL1495A , Lot Number 23HBF407 ;
DYNDL1495A , Lot Number 23IBR368 ;
DYNDL1495A , Lot Number 23KBF026 ;
DYNDL1495AH, Lot Number 22LBJ768 ;
DYNDL1495AH, Lot Number 23ABG899 ;
DYNDL1495AH, Lot Number 23CBF146 ;
DYNDL1495AH, Lot Number 23DBO301 ;
DYNDL1495AH, Lot Number 23EBC524 ;
DYNDL1495AH, Lot Number 23EBR564 ;
DYNDL1495AH, Lot Number 23GBC601 ;
DYNDL1495AH, Lot Number 23HBF407 ;
DYNDL1495AH, Lot Number 23IBR368 ;
DYNDL1495AH, Lot Number 23KBF026 ;
DYNDL1807B , Lot Number 21JBR532 ;
DYNDL1963, Lot Number 22JMG284 ;
DYNDL1963H , Lot Number 22JMG284 ;
DYNDL1965A , Lot Number 21JBJ528 ;
DYNDL1980A, Lot Number 23KBE409;
DYNDL1980AH, Lot Number 23KBE409;
DYNDL1981, Lot Number 22GBU753 ;
DYNDL1981, Lot Number 22LBS274 ;
DYNDL1981, Lot Number 23ABL575 ;
DYNDL1981, Lot Number 23BBJ949 ;
DYNDL1981, Lot Number 23CBG983 ;
DYNDL1985, Lot Number 22JBN831 ;
DYNDL1985, Lot Number 23CBQ478 ;
DYNDL1985, Lot Number 23DBF367 ;
DYNDL1986, Lot Number 22LBJ084 ;
DYNDL1986, Lot Number 23FBO474 ;
DYNDL1986, Lot Number 23GBE045 ;
DYNDL1989, Lot Number 23DBN197 ;
DYNDL1989, Lot Number 23FBB552 ;
DYNDL1989, Lot Number 23GBR197 ;
DYNDL1991, Lot Number 23IMG395 ;
DYNDL1992, Lot Number 23IBH341 ;
DYNDL1992, Lot Number 23KBA670 ;
DYNDL1992H , Lot Number 23IBH341 ;
DYNDL1992H , Lot Number 23KBA670 ;
DYNDL1993, Lot Number 23JBP617 ;
DYNDL1994, Lot Number 23KBF825 ;
DYNDL1994, Lot Number 23LBV214 ;
DYNJ0807503N , Lot Number 23FME235 ;
DYNJ52157I , Lot Number 23EBQ422 ;
DYNJ52157I , Lot Number 23FBO768 ;
DYNJ52157I , Lot Number 23HBG369 ;
DYNJ52157I , Lot Number 23KBJ323 ;
DYNJ54326A , Lot Number 23AME179 ;
DYNJ54326A , Lot Number 23AME557 ;
DYNJ56987C , Lot Number 22ABW610 ;
DYNJ56987C , Lot Number 22DBL196 ;
DYNJ56987C , Lot Number 22FBT303 ;
DYNJ56987C , Lot Number 22GBV087 ;
DYNJ56987C , Lot Number 22HBA077 ;
DYNJ56987C , Lot Number 22HBG952 ;
DYNJ56987C , Lot Number 22JBP791 ;
DYNJ56987C , Lot Number 23DBR364 ;
DYNJ56987C , Lot Number 23EBO053 ;
DYNJ56987C , Lot Number 23FBJ914 ;
DYNJ57577A , Lot Number 23KBB899 ;
DYNJ67429B , Lot Number 23HBM022 ;
DYNJ67429B , Lot Number 23LBH577 ;
DYNJ68267B , Lot Number 23JBS852 ;
DYNJ68267B , Lot Number 23LBC084 ;
DYNJ80585B , Lot Number 23JBO457 ;
DYNJRA1583D, Lot Number 23BBO987 ;
DYNJRA1583D, Lot Number 23CBK029 ;
DYNJRA1583D, Lot Number 23DBO695 ;
DYNJRA1583D, Lot Number 23EBQ098 ;
DYNJRA1583D, Lot Number 23GBE489 ;
DYNJRA1583D, Lot Number 23HBT552 ;
DYNJRA1583D, Lot Number 23JBM501 ;
DYNJRA1583D, Lot Number 23JBO381 ;
DYNJRA1583D, Lot Number 23JBW239 ;
M101498, Lot Number 23FBL279 ;
M101498, Lot Number 23HBT746 ;
M101498, Lot Number 23IBM609 ;
M101498, Lot Number 23JBY348 ;
PHS751688G, Lot Number 22GME957;
PHS751688G , Lot Number 22JME303 ;
PHS751688G , Lot Number 22LMA157 ;
PHS751688G , Lot Number 23EMC745 ;
PHS751688G , Lot Number 23GMF501 ;
PHS751688G , Lot Number 23HMI688 ;
PHS751688G , Lot Number 23IMI261 ;
PHS751688G , Lot Number 23LMG060 ;
PHS863717D , Lot Number 23HMA623 ;
SUT17215A, Lot Number 21JBR416 ;
SUT17215A, Lot Number 21LBD248 ;
SUT17215A, Lot Number 21LBH077 ;
SUT17215A, Lot Number 22ABU681 ;
SUT17215A, Lot Number 22BBH582 ;
SUT17215A, Lot Number 22FBV156 ;
SUT17215A, Lot Number 22GBD888 ;
SUT17215A, Lot Number 22HBN609 ;
SUT17215A, Lot Number 22KBG540 ;
SUT17215A, Lot Number 23FBF413 ;
SUT17215A, Lot Number 23IBD809 ;
SUT17215A, Lot Number 23IBM566 ;
SUT17215A, Lot Number 23KBL557 ;
SUT18200 , Lot Number 22FBT088 ;
SUT18200 , Lot Number 22GBL911 ;
SUT18200 , Lot Number 22HBJ926 ;
SUT20285A, Lot Number 23LBS386;
SUT20285A, Lot Number 23JBS506;
SUT20285A, Lot Number 23IBI056;
SUT20285A, Lot Number 23GBW843;
SUT20285A, Lot Number 23FBE166;
SUT20285A, Lot Number 23EBU296;
SUT20285A, Lot Number 23LBS386;
SUT20285A, Lot Number 23JBS506;
SUT20285A, Lot Number 23IBI056;
SUT20285A, Lot Number 23GBW843;
SUT20285A, Lot Number 23FBE166;
SUT20285A, Lot Number 23EBU296;
SUT20595A, Lot Number 24ABC621;
SUT20595A, Lot Number 23JBQ538;
SUT20595A, Lot Number 23HBK602;
SUT20595A, Lot Number 23FBR371;
SUT20595A, Lot Number 23DBE268;
SUT20595A, Lot Number 23ABS718;
SUT21665, Lot Number 24ABU830;
SUT21665, Lot Number 23HBW402;
SUT21665, Lot Number 22LBM554;
SUT21665, Lot Number 22LBH669;
SUT21665, Lot Number 22BBP538;
SUT21710 , Lot Number 22EBP025 ;
SUT21710 , Lot Number 22KBU033 ;
SUT21710 , Lot Number 22LBO669 ;
SUT21710 , Lot Number 23EBA694 ;
SUT21710 , Lot Number 23FBK814 ;
SUT21710 , Lot Number 23HBU140 ;
SUT21710 , Lot Number 23KBO838 ;
SUT21710 , Lot Number 23KBV154 ;
SUT21780 , Lot Number 23HBJ842 ;
SUT21825 , Lot Number 23JBM130 |
Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Karin Johnson
886-359-1704 |
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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. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| 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 these 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. |
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| Distribution | Worldwide distribution. |
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| 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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