| | Class 2 Device Recall namic |  |
| Date Initiated by Firm | February 12, 2025 |
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| Date Posted | March 21, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1431-2025 |
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| Recall Event ID |
96367 |
| Product Classification |
Cardiovascular procedure kit - Product Code OEZ
|
| Product | namic convenience kits labeled as:
1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, REF 60010468;
2) MTS,RIGHT HEART,KIT,W/TRANS,ST. *, REF 60010511;
3) MTS,LT,HT,KIT-BRYAN,LGH,M.C.,EAST, REF 60020323;
4) MTO,RIGHT,KIT-BRONSON,M* HOSP PG, REF 60020676;
5) MTS,LEFT HEART,KIT-C*,MEM HLTHCARE, REF 60035977;
6) MTS,LEFT HEART,KIT,J*,M*,C*, REF 60040273;
7) MTS,LEFT HEART,KIT,C*,C*, REF 60100313;
8) MTS,3V,KIT-M*,MEMORIAL, REF 60131208;
9) MTS,3V,KIT-M*,MEMORIAL, REF 60131208;
10) MTO,LEFT HEART,KIT,-,N* HOSPITAL PG, REF 60140101;
11) MTO,LEFT HEART,KIT,-,N* HOSPITAL PG, REF 60140101;
12) MTS,LEFT HEART,MAN,KIT,S*-BALTIMORE, REF 60190947;
13) MTS-LEFT HEART,KIT-W*,H* HOSP PG, REF 60231052;
14) MTO,3-VALVE,KIT-T*,A*-PG, REF 65190182;
15) MTO,LEFT HEART,KIT,-,S* F*,-,PG, REF 65190474;
16) MTS,DR.,MCKAYS,4V,KIT,-,H* HOSP PG, REF 600800516;
17) MTS,EP,KIT,-,S*,TEACHING HOSPITAL PG, REF 601309013;
18) MTS,RHT,HRT-S* HOSP &,MC, REF 601905413;
19) MTS,PEDS,LFT,&,RT,HRT-S* HOSP, REF 601905414;
20) MTO,SCH,BEL,J*,H*-ST-PAUL,-,PG, REF 606604328;
21) LHK,-,MID,3VCOMP,OFF,PS,S10RA, REF 613000122;
22) MTS,LHK,W* HOSPITAL, REF 6010034281;
23) MTS,LHK,W* HOSPITAL, REF 6010034281;
24) MTS,LHK,P*,P* MED CTR, REF 6010171931;
25) MTS,LHK,M* HEALTHCARE,MGMT, REF 6061073001;
26) TVR US B* INTEGRATED SERVICE CENT, REF 601316711A;
27) LHK-S* MEDICAL CENTER,A*, REF 60190776A;
28) LHK,-,S*,AND,W* HOSPITAL, REF 60191118A. |
|---|
| Code Information |
1) REF60010468, UDI/DI 10193489040319 (each) 20193489040316 (case), Lot Number 0000140099;
2) REF60010511, UDI/DI 10193489040357 (each) 20193489040354 (case), Lot Number 0000141267;
3) REF60020323, UDI/DI 10193489041071 (each) 20193489041078 (case), Lot Number 0000139976;
4) REF60020676, UDI/DI 10193489041200 (each) 20193489041207 (case), Lot Number 0000140410;
5) REF60035977, UDI/DI 10193489042672 (each) 20193489042679 (case), Lot Number 0000140081;
6) REF60040273, UDI/DI 10193489042832 (each) 20193489042839 (case), Lot Number 0000140896;
7) REF60100313, UDI/DI 10193489045048 (each) 20193489045045 (case), Lot Number 0000140520;
8) REF60131208, UDI/DI 10193489046762 (each) 20193489046769 (case), Lot Number 0000140075;
9) REF60131208, UDI/DI 10193489046762 (each) 20193489046769 (case), Lot Number 0000140364;
10) REF60140101, UDI/DI 10193489047868 (each) 20193489047865 (case), Lot Number 0000139979;
11) REF60140101, UDI/DI 10193489047868 (each) 20193489047865 (case), Lot Number 0000140016;
12) REF60190947, UDI/DI 10193489050677 (each) 20193489050674 (case), Lot Number 0000140835;
13) REF60231052, UDI/DI 10193489053203 (each) 20193489053200 (case), Lot Number 0000140045;
14) REF65190182, UDI/DI 10193489063028 (each) 20193489063025 (case), Lot Number 0000140258;
15) REF65190474, UDI/DI 10193489063059 (each) 20193489063056 (case), Lot Number 0000141271;
16) REF600800516, UDI/DI 10193489070347 (each) 20193489070344 (case), Lot Number 0000140829;
17) REF601309013, UDI/DI 10193489071054 (each) 20193489071051 (case), Lot Number 0000139959;
18) REF601905413, UDI/DI 10193489072099 (each) 20193489072096 (case), Lot Number 0000139674;
19) REF601905414, UDI/DI 10193489072105 (each) 20193489072102 (case), Lot Number 0000139097;
20) REF606604328, UDI/DI 10193489073898 (each) 20193489073895 (case), Lot Number 0000140043;
21) REF613000122, UDI/DI 10193489074482 (each) 20193489074489 (case), Lot Number 0000140963;
22) REF6010034281, UDI/DI 10193489095951 (each) 20193489095958 (case), Lot Number 0000139656;
23) REF6010034281, UDI/DI 10193489095951 (each) 20193489095958 (case), Lot Number 0000140079;
24) REF6010171931, UDI/DI 10193489104943 (each) 20193489104940 (case), Lot Number 0000140976;
25) REF6061073001, UDI/DI 10193489095692 (each) 20193489095699 (case), Lot Number 0000140936;
26) REF601316711A, UDI/DI 10197344028696 (each) 20197344028693 (case), Lot Number 0000139675;
27) REF60190776A, UDI/DI 10193489148763 (each) 20193489148760 (case), Lot Number 0000140484;
28) REF60191118A, UDI/DI 10193489180657 (each) 20193489180654 (case), Lot Number 0000139969. |
| FEI Number |
1417592
|
Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Haley Barclay
866-359-1704 |
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Manufacturer Reason
for Recall | The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway. |
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FDA Determined
Cause 2 | Process change control |
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| Action | Medline Industries issued two notices, delivered using email and US Mail: 1) a MEDICAL DEVICE RECALL notice for the affected Pressure Monitoring Lines and 2) a MEDICAL DEVICE RECALL notice for the kits containing the affected product; both notices explained the issue and the hazard.
The MEDICAL DEVICE RECALL notice for the affected Pressure Monitoring Lines requested that the consignee destroy any affected inventory and reply to receive credit. The MEDICAL DEVICE RECALL notice for the kits containing the affected product requested the consignee respond to the notice and upon response, Medline will provide labeling that states the following: "ATTENTION This kit contains a recalled item Medline Pressure Monitoring Lines VPN: 24614303 DO NOT USE THIS COMPONENT The rest of the kit may be used.
Please remove this item only and replace with product from supply. *Do not cover or remove this sticker*"
Consignees were directed to notify their customers of these actions. |
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| Quantity in Commerce | 1669 units |
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| Distribution | Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia |
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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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