Reported Feb 15, 2023 · Ongoing
Sterile Procedural Trays, labeled as the following: a. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS…
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. EAR CDS-LF b. SINUS CDS-1 c. ZALE FESS CDS d. ZALE OTOLOGY CDS e. ZALE HEAD & NECK CDS f. CUH PARA/THYROIDECTOMY CDS g. CAM ENDOSCOPIC SINUS/SEPTO CDS h. HEAD AND NECK CDS i. HEAD AND NECK CDS-LF j. NASAL k. ENT SET UP CDS l. MINOR ENT SINUS PACK-LF m. MAJOR EAR PACK-LF n. THORACOTOMY HARPER PACK-LF o. FESS NSR PACK-LF p. ENT BASIC PACK-LF q. HEAD & NECK-LF r. ENT PACK-LF s. SINOSCOPY-LF t. MAJOR HEAD/NECK PACK-LF u. NECK PACK v. HEAD & NECK PACK w. HEAD & NECK TRAY x. ENT LAW PACK-LF y. ENT PACK z. NECK PACK aa. NASAL PACK bb. ENT PACK cc. FREE FLAP PACK-LF dd. TYMPANO MASTOID ee. MINOR HEAD & NECK #40-RF ff. EAR PACK gg. E.N.T. TRAY hh. EAR PACK-LF ii. BASIC ENT PACK-LF jj. PLASTIC HEAD & NECK PACK kk. EAR TRAY #10-RF ll. HEAD & NECK ENT PACK-RF-LF mm. ENT PACK nn. ENT PACK-LF oo. NASAL/SEPTO PACK pp. OSC FACE LIFT PK qq. RRMC NASAL PACK rr. ENT PACK ss. HENRYS ENT PACK tt. ENT uu. FACE AND NASAL PACK vv. NASAL PACK ww. ENT PACK xx. SINUS ENDOSCOPY-LF yy. OSC NASAL-NOSE PACK-LF zz. ENT PACK aaa. FES PACK - LF bbb. HEAD AND NECK PACK ccc. SCRIPPS SW ENT PACK ddd. SCRIPPS SW EAR PACK-LF eee. HL ENT PACK fff. CAROTID ENDARTECTOMY PK ggg. EAR PACK hhh. ENT FREE FLAP iii. HEAD AND NECK PACK jjj. TRACH PACK kkk. HL EAR PACK lll. NASAL SINUS ENDO PK mmm. ENT PACK nnn. HEAD AND NECK PACK ooo. ENT PACK ppp. HEAD AND NECK PACK qqq. ASC HEAD & NECK PACK rrr. ENT PACK sss. DEACONESS HEAD AND NECK PACK ttt. ENT PACK uuu. BEC MOHS PACK vvv. PK,ENT-EAR www. SVMMC HEAD AND NECK PACK xxx. PK, ENT yyy. HEAD AND NECK PACK zzz. FESS PACK aaaa. PK,ENT-SINUS bbbb. NASAL/HEAD & NECK PACK cccc. ENT PACK dddd. ENT PACK eeee. MAJOR ENT PACK ffff. ENT NECK MMC PACK gggg. HEAD AND NECK PACK hhhh. HEAD AND NECK PACK iiii. HEAD AND NECK PACK jjjj. ORAL PACK kkkk. HMT THORACOSCOPY PACK llll. GU PACK mmmm. HEAD NECKPACK (HNSJC)227-LF nnnn. HEAD AND NECK PLUS I PACK oooo. NASAL PACK pppp. HEAD & NECK PACK-RFD-LF qqqq. ENT PACK rrrr. ENT/H&N PACK ssss. C-SECTION PACK tttt. ENT PACK uuuu. ENT PACK vvvv. ENT PACK wwww. NASAL ENT PACK xxxx. SINUS PACK yyyy. HEAD/NECK PACK zzzz. ENT PACK aaaaa. NASAL PACK bbbbb. FESS PACK ccccc. NASAL SEPTOPLASTY PACK ddddd. ENT PACK eeeee. HEAD&NECK fffff. EAR PACK-LF ggggg. HEAD AND NECK PACK-LF hhhhh. EAR BASIC PACK iiiii. HEAD AND NECK PACK jjjjj. ENT/SEPTO PACK kkkkk. ENT PACK lllll. HEAD & NECK PACK mmmmm. HEAD AND NECK PACK nnnnn. ENT PACK ooooo. ENT PACK-LF ppppp. ENT PACK-LF qqqqq. HL DR PETERS ENT PACK rrrrr. RHINO/SEPTO/FESS PACK sssss. HEAD & NECK ttttt. THYROID/PARATHYROID PACK uuuuu. HEAD AND NECK MINOR PACK vvvvv. PK,ENT wwwww. ENT PACK xxxxx. ENT PACK yyyyy. ENT PACK zzzzz. ENT NECK PACK aaaaaa. ENT PACK bbbbbb. NECK PACK cccccc. EAR TRAY dddddd. HEAD & NECK PACK eeeeee. HEAD & NECK PACK ffffff. MHPB HEAD AND NECK PACK gggggg. NASAL PACK hhhhhh. ENT PACK iiiiii. JHOC EAR TRAY jjjjjj. JHOC HEAD TRAY kkkkkk. ENT I llllll. ENT SHARED mmmmmm. ENT PACK nnnnnn. EENT SPLIT PACK-NO GPAD oooooo. ENT PACK pppppp. HEAD & NECK PACK qqqqqq. NASAL PACK rrrrrr. ENT PACK ssssss. ENT PACK tttttt. ENT PACK uuuuuu. ENT PACK vvvvvv. ENT PACK-LF wwwwww. ENT I-LF xxxxxx. MAJOR HEAD AND NECK PACK yyyyyy. HEAD AND NECK PACK zzzzzz. FACE AND NECK aaaaaaa. ENT PACK bbbbbbb. ENT PACK ccccccc. ENT BASIC PACK-LF ddddddd. ENT PACK-LF eeeeeee. PK, ENT-H&N fffffff. ENT PACK ggggggg. SPRINGS HEAD AND NECK PACK hhhhhhh. ENDO SINUS PACK iiiiiii. HEAD/NECK PACK jjjjjjj. ENT/SINUS PACK-LF kkkkkkk. ENT PACK lllllll. NASAL PACK mmmmmmm. ENT PACK nnnnnnn. ORAL PLASTIC FACIAL PACK ooooooo. ENT HEAD NECK PACK ppppppp. THYROIDECTOMY PACK qqqqqqq. MINOR ORL PACK rrrrrrr. EAR CUSTOM PACK sssssss. MG NS ENT PACK ttttttt. HEAD AND NECK PACK uuuuuuu. ENT PACK vvvvvvv. MAJOR ENT PACK wwwwwww. ENT xxxxxxx. NASAL EAR yyyyyyy. NASAL-LF zzzzzzz. LARGE ENT aaaaaaaa. EAR bbbbbbbb. HEAD AND NECK cccccccc. PAD ENT HEAD & NECK dddddddd. FHT CVOR TAVR eeeeeeee. MODULE NASAL NATALIE ffffffff. ENT-LF gggggggg. HEA
- Lot codes and dates
26 of 26 products
Products covered by this recall Model / number Barcodes Product as published 1088827789972840888277899729EAR CDS-LF, Item Number: CDS982612B, Case UDI/GTIN: 40888277899729, Unit UDI/ , Lot Number: 22JBH351,22JBA043 1088994221697040889942216971SINUS CDS-1, Item Number: CDS982901F, Case UDI/GTIN: 40889942216971, Unit UDI/ , Lot Number: 22KBD129 1019532716463840195327164639ZALE FESS CDS, Item Number: CDS983178F, Case UDI/GTIN: 40195327164639, Unit UDI/ , Lot Number: 22JBC334,22IBC429 1019532716464540195327164646ZALE OTOLOGY CDS, Item Number: CDS983181F, Case UDI/GTIN: 40195327164646, Unit UDI/ , Lot Number: 22IBQ523,22IBJ058 1019532717835240195327178353ZALE HEAD & NECK CDS, Item Number: CDS983184I, Case UDI/GTIN: 40195327178353, Unit UDI/ , Lot Number: 22IBO795,22IBJ687 1019532717979340195327179794CUH PARA/THYROIDECTOMY CDS, Item Number: CDS983209J, Case UDI/GTIN: 40195327179794, Unit UDI/ , Lot Number: 22JBC280 1019348974975540193489749756CAM ENDOSCOPIC SINUS/SEPTO CDS, Item Number: CDS983499D, Case UDI/GTIN: 40193489749756, Unit UDI/ , Lot Number: 22IBU380,22HBW179 1019532725659340195327256594HEAD AND NECK CDS, Item Number: CDS983910K, Case UDI/GTIN: 40195327256594, Unit UDI/ , Lot Number: 22JBT244 1019532709080740195327090808HEAD AND NECK CDS-LF, Item Number: CDS984857J, Case UDI/GTIN: 40195327090808, Unit UDI/ , Lot Number: 22JDB038,22IDA739 1019348998382140193489983822NASAL, Item Number: CDS984899G, Case UDI/GTIN: 40193489983822, Unit UDI/ , Lot Number: 22IBC505 1019348931930940193489319300ENT SET UP CDS, Item Number: CDS985421G, Case UDI/GTIN: 40193489319300, Unit UDI/ , Lot Number: 22KBG050,22HBX042 1019348935235140193489352352MINOR ENT SINUS PACK-LF, Item Number: DYNJ0101278F, Case UDI/GTIN: 40193489352352, Unit UDI/ , Lot Number: 22HDC403 1019348945109240193489451093MAJOR EAR PACK-LF, Item Number: DYNJ0101314C, Case UDI/GTIN: 40193489451093, Unit UDI/ , Lot Number: 22JDA679,22HDC440 1088994221662840889942216629THORACOTOMY HARPER PACK-LF, Item Number: DYNJ0161795C, Case UDI/GTIN: 40889942216629, Unit UDI/ , Lot Number: 22IDB179 1019348947531940193489475310FESS NSR PACK-LF, Item Number: DYNJ0381496I, Case UDI/GTIN: 40193489475310, Unit UDI/ , Lot Number: 22JBH235 1019532727015540195327270156ENT BASIC PACK-LF, Item Number: DYNJ0387711D, Case UDI/GTIN: 40195327270156, Unit UDI/ , Lot Number: 22JMI201 1019348927449340193489274494HEAD & NECK-LF, Item Number: DYNJ04437J, Case UDI/GTIN: 40193489274494, Unit UDI/ , Lot Number: 22JMI207 1019348955143340193489551434ENT PACK-LF, Item Number: DYNJ04591F, Case UDI/GTIN: 40193489551434, Unit UDI/ , Lot Number: 22JMH877 1088827785469740888277854698SINOSCOPY-LF, Item Number: DYNJ06621D, Case UDI/GTIN: 40888277854698, Unit UDI/ , Lot Number: 22JBM104,22HBX999 1019348926568240193489265683MAJOR HEAD/NECK PACK-LF, Item Number: DYNJ0826705N, Case UDI/GTIN: 40193489265683, Unit UDI/ , Lot Number: 22JMD563,22JMD586 - Amount recalled
- 9,079 cases (27,563 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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