Reported Feb 15, 2023 · Ongoing
Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA…
MEDLINE INDUSTRIES, LP - Northfield
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
- Sterile Procedural Trays
- labeled as the followinga. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PACEMAKER CDS g. HEART CDS h. VALVE PACK i. OPEN HEART CDS-3 j. OPEN HEART PACK k. OPEN HEART PACK l. OPEN HEART ADULT m. OPEN HEART CDS PART A n. GLENNON OPEN HEART CDS o. OPEN HEART CDS p. MEMORIAL MED CTR BYPASS q. OPEN HEART PEDS r. OPEN HEART CDS-4 s. OPEN HEART t. CAB CDS u. VASCULAR CDS v. VALVE CDS w. OPEN HEART PACK-LF x. VASCULAR CDS-LF y. OPEN HEART B CDS-LF z. CRANIOTOMY CDS aa. OPEN UROLOGY CDS-LF bb. TOTAL KNEE CDS cc. LOWER EXTREMITY CDS-LF dd. LAMINECTOMY CDS ee. ENDOVASCULAR CDS ff. VASCULAR gg. VASCULAR CDS-3 hh. VASCULAR ACCESS CDS ii. ZALE PUMP CDS jj. CUH ENDOVASCULAR CDS kk. CUH MINOR VASCULAR CDS ll. FHT CVOR CABG mm. OPEN HEART CDS nn. OPEN HEART CDS oo. CAROTID ENDARTERECTOMY CDS-LF pp. PACER CDS qq. PERIPHERAL VASCULAR CDS rr. ACH OPEN HEART ss. ACH OPEN HEART tt. OPEN HEART CDS uu. VASCULAR CDS vv. CV CDS ww. OPEN HEART CABG PACK-LF xx. MAJOR VASCULAR PACK-LF yy. CARDIOVASCULAR PACK-LF zz. VASCULAR HARPER PACK-LF aaa. CABG 1 OR 2 HARPER PACK bbb. TAVR 1 PACK-LF ccc. ENDO VASCULAR PACK-LF ddd. OPEN HEART A & B PACK eee. PACEMAKER IMPLANT PACK-LF fff. PERIPHERAL VASCULAR PACK-LF ggg. PACEMAKER PACK-LF hhh. RR-NEURO VASCULAR PACK-LF iii. CARDIAC CHEST PACK 80701 jjj. OPEN HEART PACK-LF kkk. PACEMAKER PACK-LF lll. CARDIOVASCULAR PACK-LF mmm. OPEN HEART PACK A & B nnn. MINOR VASCULAR PACK ooo. OPEN HEART PACK-LF ppp. SMALL VASCULAR PACK-LF qqq. MAJOR VASCULAR PACK-LF rrr. PEDIATRIC CARDIAC PACK-LF sss. OH VALVE PACK-LF ttt. HEART OVERHEAD TABLE PACK uuu. OPEN HEART PACK vvv. PACEMAKER PACK-LF www. VASCULAR PACK-LF xxx. OPEN HEART PACK yyy. VASCULAR PACK zzz. CV BASIC SET UP PACK aaaa. UNIVERSAL OPEN HEART PACK bbbb. VASCULAR BYPASS PACK-LF cccc. BMC CABG PACK A dddd. CUSTOM CAROTID eeee. A-V FISTULA PACK-LF ffff. PERIPHERAL VASCULAR PACK-LF gggg. ECMO PACK hhhh. HEART PACK iiii. CABG PACK A&B jjjj. OPEN HEART PACK kkkk. CV A & B llll. PEDIATRIC OPEN HEART-NS-LF mmmm. PACEMAKER NORTH nnnn. OPEN HEART PACK oooo. SVMMC CORE OPEN HEART PACK-LF pppp. PACEMAKER TRAY-LF qqqq. PACEMAKER PACK rrrr. MAJOR VASCULAR-RF-LF ssss. AV FISTULA-LF tttt. PACEMAKER PACK uuuu. VASCULAR PACK vvvv. PACEMAKER wwww. MAJOR VASCULAR PACK xxxx. MAJOR VASCULAR PACK yyyy. VASCULAR PACK zzzz. PACEMAKER PACK-LF aaaaa. RRMC CABG AUXILIARY TRAY bbbbb. RRMC OPEN HEART PACK ccccc. MAJOR VASCULAR PACK ddddd. PACEMAKER PACK eeeee. PACEMAKER TRAY fffff. PACEMAKER PACK ggggg. PACEMAKER PACK hhhhh. AV FISTULA PK-LF iiiii. FHT PACER PACK jjjjj. PACEMAKER SET UP PACK kkkkk. MAJOR VASCULAR PACK lllll. PACEMAKER PACK-LF mmmmm. CAROTID PACK nnnnn. MAJOR VASCULAR PACK ooooo. VASCULAR PACK GH-LF ppppp. A-V FISTULA PACK GH-LF qqqqq. VASCULAR PACK MH-LF rrrrr. PACEMAKER PACK L J sssss. OPEN HEART ttttt. OPEN HEART SUPPLY TRAY uuuuu. PACEMAKER PACK vvvvv. PACEMAKER PACK wwwww. VASCULAR PACK xxxxx. BASIC OPEN HEART PACK A B yyyyy. VASCULAR PACK zzzzz. OPEN HEART TRAY A-LF aaaaaa. VASCULAR PACK bbbbbb. PACEMAKER PACK cccccc. OPEN HEART PACK dddddd. ENDOVASCULAR PACK-LF eeeeee. VASCULAR PACK-LF ffffff. BASIC OPEN HEART PACK-LF gggggg. OPEN VASCULAR PACK-LF hhhhhh. PK, EP LAB PACEMAKER iiiiii. PK, OPEN HEART-CABG jjjjjj. OPEN HEART PACK kkkkkk. PK, OPEN HEART- A&B llllll. SVMMC VASCULAR MAJOR PACK mmmmmm. CV PACK nnnnnn. OPEN HEART PACK A AND B oooooo. SVMMC CAROTID PACK pppppp. PK, OPEN HEART-CABG A&B qqqqqq. PK, OPEN HEART-A&B rrrrrr. VASCULAR PACK ssssss. PK, OPEN HEART tttttt. PK, OPEN HEART uuuuuu. OPEN HEART PACK vvvvvv. PK, OPEN HEART-A&B wwwwww. OPEN HEART PACK xxxxxx. PK, OPEN HEART-CABG yyyyyy. PK, OPEN HEART zzzzzz. CASTRO CABG-COMPONENT PACK aaaaaaa. RE-ENTRY PACK bbbbbbb. HEART PACK ccccccc. OPEN HEART SUPPLY PACK ddddddd. PK, OPEN HEART-CABG eeeeeee. CABG PROCEDURE PACK fffffff. CABG PACK ggggggg. PK, OPEN HEART hhhhhhh. VASCULAR GRAFT PACK iiiiiii. PK, OPEN HEART jjjjjjj. VASCULAR PACK kkkkkkk. PK
- Lot codes and dates
26 of 26 products
Products covered by this recall Model / number Barcodes Product as published 1019532712788640195327127887EP LAB PACEMAKER PACK, Item Number: 00-401893L, Case UDI/GTIN: 40195327127887, Unit UDI/ , Lot Number: 22JMC769 1019348974184140193489741842OPEN HEART CDS, Item Number: CDS840016AD, Case UDI/GTIN: 40193489741842, Unit UDI/ , Lot Number: 22KBB889 1019348968206940193489682060OPEN HEART CDS, Item Number: CDS840023T, Case UDI/GTIN: 40193489682060, Unit UDI/ , Lot Number: 22JBU353,22JBT770 1019532720962940195327209620AAA CDS, Item Number: CDS840076AC, Case UDI/GTIN: 40195327209620, Unit UDI/ , Lot Number: 22KBE518 1019532708951140195327089512OPEN HEART CDS, Item Number: CDS840094N, Case UDI/GTIN: 40195327089512, Unit UDI/ , Lot Number: 22JBI258,22IBF817 1019348948062740193489480628PACEMAKER CDS, Item Number: CDS840162V, Case UDI/GTIN: 40193489480628, Unit UDI/ , Lot Number: 22KBG388,22IBP339 1088994289400040889942894001HEART CDS, Item Number: CDS840179M, Case UDI/GTIN: 40889942894001, Unit UDI/ , Lot Number: 22JBJ710,22IBQ944 1019348981646440193489816465VALVE PACK, Item Number: CDS840187T, Case UDI/GTIN: 40193489816465, Unit UDI/ , Lot Number: 22JMG653 1088994221742740889942217428OPEN HEART CDS-3, Item Number: CDS840246N, Case UDI/GTIN: 40889942217428, Unit UDI/ , Lot Number: 22JLB009,22JLA126,22ILB075 1019532725929740195327259298OPEN HEART PACK, Item Number: CDS840332Y, Case UDI/GTIN: 40195327259298, Unit UDI/ , Lot Number: 22KLA079 1019532718854240195327188543OPEN HEART PACK, Item Number: CDS840393M, Case UDI/GTIN: 40195327188543, Unit UDI/ , Lot Number: 22KBD842 1019348946191640193489461917OPEN HEART ADULT, Item Number: CDS840396X, Case UDI/GTIN: 40193489461917, Unit UDI/ , Lot Number: 22JBG072,22JBG077,22JBG079 1019532725511440195327255115OPEN HEART CDS PART A, Item Number: CDS840402AG, Case UDI/GTIN: 40195327255115, Unit UDI/ , Lot Number: 22JLA474 1019532707223040195327072231GLENNON OPEN HEART CDS, Item Number: CDS840412N, Case UDI/GTIN: 40195327072231, Unit UDI/ , Lot Number: 22JBG206 1088827774979540888277749796OPEN HEART CDS, Item Number: CDS840483K, Case UDI/GTIN: 40888277749796, Unit UDI/ , Lot Number: 22IBR228 1088827781411040888277814111MEMORIAL MED CTR BYPASS, Item Number: CDS901660, Case UDI/GTIN: 40888277814111, Unit UDI/ , Lot Number: 22KBA999,22JBL553 1088994286466940889942864660OPEN HEART PEDS, Item Number: CDS981050Q, Case UDI/GTIN: 40889942864660, Unit UDI/ , Lot Number: 22JBH010,22IBC746,22IBC748 1088994221511940889942215110OPEN HEART CDS-4, Item Number: CDS981159J, Case UDI/GTIN: 40889942215110, Unit UDI/ , Lot Number: 22JLA895,22ILA228 1019348981746140193489817462OPEN HEART, Item Number: CDS981161AB, Case UDI/GTIN: 40193489817462, Unit UDI/ , Lot Number: 22JBT785 1019532717142140195327171422CAB CDS, Item Number: CDS981533G, Case UDI/GTIN: 40195327171422, Unit UDI/ , Lot Number: 22JBW502 - Amount recalled
- 12,964 cases (23,379 units)
This recall covers 38 products
The agency filed one notice per product. You are reading one of them; the other 37 are below.
25 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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