Reported Feb 15, 2023 · Ongoing

Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR…

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. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR CDS e. UROLOGY MAJOR CDS f. SINGLE BASIC CDS g. ORGAN RECOVERY CDS h. GENERAL ABD CDS i. BURN CDS j. MINOR k. MAJOR VASCULAR l. BASIC CORE CDS m. ROBOTIC PROCEDURE n. MAJOR VASCULAR CDS o. PEDI LITHOTOMY p. MAJOR CDS-1 q. MINOR CDS-1 r. VASCULAR CDS-4 s. SEPTOPLASTY CDS t. DENTAL CDS u. MINOR GENERAL CDS v. CUH UROLOGY LITHOTOMY CDS w. CUH UROLOGY OPEN CDS x. CUH LIVER TRANSPLANT CDS y. THORACOTOMY CDS z. XI THORACIC ROBOTIC CDS aa. GENERAL CDS bb. THORACIC CDS cc. MINOR PROCEDURE dd. EXTREMITY CDS ee. DOUBLE BASIN CDS ff. PEDIATRIC gg. P.V.STARTER TRAY hh. CV PACK ii. MINOR GENERAL-LF jj. VASCULAR PACK-LF kk. UROLOGY PACK ll. MINOR LINEN PACK-LF mm. ABDOMINAL PACK-LF nn. MINOR SURGICAL SETUP PACK-LF oo. MINOR GENERAL PACK-LF pp. MAJOR ABDOMINAL PACK-LF qq. MINOR VASCULAR PACK-LF rr. MAJOR BASIN PACK-LF ss. DAVINCI PACK-LF tt. MINOR ENT HARPER PACK-LF uu. CHOM START UP PACK-LF vv. MINOR HARPER PACK-LF ww. MAJOR ENT HARPER PACK-LF xx. THROMBECTOMY HARPER PACK-LF yy. PENILE PROSTHESIS HARPER PK-LF zz. RECONSTRUCTIVE PACK-LF aaa. CUSTOM COLIC PACK bbb. MAJOR PACK ccc. ROBOTIC PACK ddd. MINOR PACK eee. MINOR PACK-LF fff. CT THORACIC PACK ggg. KIDNEY TRANSPLANT PACK-LF hhh. DAVINCI ROBOTIC PACK iii. MAJOR UNIVERSAL PACK-LF jjj. BASIC SETUP PACK-LF kkk. BASIC ABDOMINAL PACK-LF lll. PENILE IMPLANT PACK-LF mmm. VALVE UNIV OF CINN PACK-LF nnn. CABG UNIVERSITY HOSP PACK-LF ooo. AAA - UNIV ppp. LIVER TRANSPLNT UNIV CI PK-LF qqq. AV FISTULA PACK-LF rrr. MAJOR PACK-LF sss. MINOR SNGL BASIN PACK-LF ttt. MAJOR BASIN PACK-LF uuu. MAJOR PACK L-F vvv. PEDIATRIC PACK www. BASIC PACK-LF xxx. BASIC PACK-LF yyy. MAJOR PACK-LF zzz. MAJOR PACK aaaa. MINOR PACK bbbb. UPPER EXTREMITY PACK-LF cccc. MAJOR PACK-LF dddd. DR PALEY ILIZAROV PACK-LF eeee. MAJOR PACK ffff. BASIC PACK-LF gggg. MAJOR PACK hhhh. MAJOR LITHOTOMY PACK iiii. MAJOR LITHOTOMY PACK-LF jjjj. MAJOR PACK kkkk. MAJOR PACK llll. MAJOR LITHOTOMY PACK mmmm. AMC MINOR PACK-LF nnnn. MINOR PACK-LF oooo. MAJOR LITHOTOMY PACK-LF pppp. MAJOR PACK qqqq. MAJOR PACK-LF rrrr. MINOR GENERAL PACK ssss. MINOR ACUTE PACK-LF tttt. BASIC PACK uuuu. GENERAL PACK-LF vvvv. MAJOR BASIN PACK-LF wwww. VASCULAR SSC PACK xxxx. DAVINCI PACK-LF yyyy. SINGLE BASIN PLUS 1-LF zzzz. CUSTOM LID PACK-LF aaaaa. BARIATRIC PACK-LF bbbbb. SINGLE BASIN PLUS 4-LF ccccc. MINOR OR SET-UP PACK-LF ddddd. MINOR LAP PACK eeeee. TRAUMA PACK-LF fffff. MAJOR LITHOTOMY PACK-LF ggggg. MINOR LITHOTOMY PACK-LF hhhhh. MAJOR PROCEDURE PACK-LF iiiii. MINOR PROCEDURE PACK-LF jjjjj. DEEP BRAIN STIMULATION PACK kkkkk. VOORHEES SUMMIT T AND A PK-LF lllll. BASIC PACK-LF mmmmm. ASCI BASIC PACK nnnnn. GASTRIC BY PASS PACK-LF ooooo. MINOR PACK-LF ppppp. MAJOR SET-LF qqqqq. BASIC PACK-LF rrrrr. TRMC- GENERAL SURGERY PACK sssss. TRMC- PERI GYN PACK ttttt. PEDIATRIC PACK uuuuu. PENILE PROSTHESIS PK W/AUX vvvvv. ACCOLA AVR/MVR COMPONENT PACK wwwww. ACCOLA BASIC PACK xxxxx. BASIC SET UP PACK-LF yyyyy. MAJOR ABDOMINAL PK zzzzz. THOROCOTOMY PACK-LF aaaaaa. MINOR BASIN PACK bbbbbb. MINOR PROCEDURE KIT-LF cccccc. BIRTHDAY KIT-DOUBLE BASIN-LF dddddd. VASCULAR MAJOR BASIN-LF eeeeee. SINGLE BASIN PACK ffffff. MAJOR BASIN PACK-LF gggggg. GENERAL BASIC PACK hhhhhh. BASIC PACK iiiiii. MINOR PACK jjjjjj. CV PACK A-LF kkkkkk. KIDNEY PACK-LF llllll. GENERAL SURGERY PACK-LF mmmmmm. MINOR BASIC PACK-LF nnnnnn. MAJOR LAP PK-LF oooooo. PEDI PK-LF pppppp. THORACOTOMY PK qqqqqq. PLASTIC SOFT TISSUE #51-RF rrrrrr. ADULT LIVER TRANSPLANT PK ssssss. THORACIC-RF-LF tttttt. BASIC SET UP PACK uuuuuu. MINOR BASIC TRAY SC-LF vvvvvv. BASIC MAJOR PACK-LF wwwwww. ACDF PACK xxxxxx. MAJOR PACK yyyyyy. MINOR PACK-LF zzzzzz. VASCULAR PACK-LF aaaaaaa. BASIC PACK-LF bbbbbbb. CUSTOM THORACOTOMY ccccccc. PEDIATRIC BASIC MINOR PACK-LF ddddddd. MINOR HERNIA-LF eeeeeee. MAJOR PACK-LF fffffff. MINOR SET UP PACK-LF ggggggg. CORE PACK hhhhhhh. PEDIATRIC PACK-LF iiiiiii. GENERAL PA
Lot codes and dates

26 of 26 products

Products covered by this recall
Model / numberBarcodesProduct as published
1088994261413440889942614135BASIN SET-UP PACK, Item Number: BAD079F, Case UDI/GTIN: 40889942614135, Unit UDI/ , Lot Number: 22IBR514
1088827774937540888277749376LAP CHOLE CDS, Item Number: CDS860230D, Case UDI/GTIN: 40888277749376, Unit UDI/ , Lot Number: 22JMG555
1088827790645740888277906458MAJOR CDS, Item Number: CDS980178G, Case UDI/GTIN: 40888277906458, Unit UDI/ , Lot Number: 22JMG570,22JMC877
1019532705095540195327050956UROLOGY MINOR CDS, Item Number: CDS980371L, Case UDI/GTIN: 40195327050956, Unit UDI/ , Lot Number: 22HBU946
1019532725119240195327251193UROLOGY MAJOR CDS, Item Number: CDS980383O, Case UDI/GTIN: 40195327251193, Unit UDI/ , Lot Number: 22JBV588
1019532723160640195327231607SINGLE BASIC CDS, Item Number: CDS980389O, Case UDI/GTIN: 40195327231607, Unit UDI/ , Lot Number: 22JMF540
1088827779383540888277793836ORGAN RECOVERY CDS, Item Number: CDS980556F, Case UDI/GTIN: 40888277793836, Unit UDI/ , Lot Number: 22JBO588,22IBV960
1019348954066640193489540667GENERAL ABD CDS, Item Number: CDS980628I, Case UDI/GTIN: 40193489540667, Unit UDI/ , Lot Number: 22IMG415
1019348954037640193489540377BURN CDS, Item Number: CDS980629J, Case UDI/GTIN: 40193489540377, Unit UDI/ , Lot Number: 22JMG578
1088827797749540888277977496MINOR, Item Number: CDS980749G, Case UDI/GTIN: 40888277977496, Unit UDI/ , Lot Number: 22IBE725
1088994242854040889942428541MAJOR VASCULAR, Item Number: CDS980752I, Case UDI/GTIN: 40889942428541, Unit UDI/ , Lot Number: 22JBU157,22JBB126
1019348964843040193489648431BASIC CORE CDS, Item Number: CDS982062F, Case UDI/GTIN: 40193489648431, Unit UDI/ , Lot Number: 22JBP662,22JBO884
1019348977553240193489775533ROBOTIC PROCEDURE, Item Number: CDS982128O, Case UDI/GTIN: 40193489775533, Unit UDI/ , Lot Number: 22JBO084,22JBJ689
1088827773707540888277737076MAJOR VASCULAR CDS, Item Number: CDS982613G, Case UDI/GTIN: 40888277737076, Unit UDI/ , Lot Number: 22JBK713
1019348941820040193489418201PEDI LITHOTOMY, Item Number: CDS982718K, Case UDI/GTIN: 40193489418201, Unit UDI/ , Lot Number: 22JBR860,22JBK829,22IBH995
1088994221741040889942217411MAJOR CDS-1, Item Number: CDS982898G, Case UDI/GTIN: 40889942217411, Unit UDI/ , Lot Number: 22IBO658,22IBN353,22IBF023
1088994221693240889942216933MINOR CDS-1, Item Number: CDS982899F, Case UDI/GTIN: 40889942216933, Unit UDI/ , Lot Number: 22KBD131,22IBU676,22IBD867
1088994221745840889942217459VASCULAR CDS-4, Item Number: CDS983003F, Case UDI/GTIN: 40889942217459, Unit UDI/ , Lot Number: 22JBG357,22IBQ259
1088994292676340889942926764SEPTOPLASTY CDS, Item Number: CDS983100C, Case UDI/GTIN: 40889942926764, Unit UDI/ , Lot Number: 22JBB204
1088994292667140889942926672DENTAL CDS, Item Number: CDS983103C, Case UDI/GTIN: 40889942926672, Unit UDI/ , Lot Number: 22JBR350,22JBO090,22JBJ684
Amount recalled
62,930 cases (215,456 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:32 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.