Reported Feb 15, 2023 · Ongoing
Sterile Procedural Trays, labeled as the following: a. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e.…
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. GYN ABD CDS b. LAVH PROCEDURE c. TAH CDS d. CUH LITHOTOMY CDS e. LAVH CDS f. GROTH VAGINAL CDS g. MAJOR LITHOTOMY h. MAJOR VAGINAL HARPER PACK-LF i. VAG. HYST TRAY-LF j. VAGINAL HYSTERECTOMY PACK-LF k. HYSTERECTOMY PACK-LF l. HYSTERECTOMY PACK m. MAJOR ABD PROCEDURE PACK-LF n. GYN PACK o. BLADDER SLING PACK p. PERI/GYN PACK-RFD q. ROBOT HYSTERECTOMY r. VAG HYST s. GYN MAJOR PACK t. VAGINAL HYSTER PROCEDURE u. TLH PACK v. TLH PACK w. VAG HYST PACK x. LITHOTOMY-LF y. MAJOR LITHOTOMY z. LAVH aa. LAVH bb. D&C / GYN cc. LAPAROSCOPIC HYSTERECTOMY dd. FS LAP TUBAL LIGATION ee. LAVH ff. ABD HYST PACK-LF gg. VAG HYST PK-LF
- Lot codes and dates
26 of 26 products
Products covered by this recall Model / number Barcodes Product as published 1088994211004940889942110040GYN ABD CDS, Item Number: CDS830215G, Case UDI/GTIN: 40889942110040, Unit UDI/ , Lot Number: 22IMD263 1019532700869740195327008698LAVH PROCEDURE, Item Number: CDS980754R, Case UDI/GTIN: 40195327008698, Unit UDI/ , Lot Number: 22JME637 1019348965126340193489651264TAH CDS, Item Number: CDS982249I, Case UDI/GTIN: 40193489651264, Unit UDI/ , Lot Number: 22JBM626,22JBK303 1019532716460740195327164608CUH LITHOTOMY CDS, Item Number: CDS983207M, Case UDI/GTIN: 40195327164608, Unit UDI/ , Lot Number: 22JBM359 1019348941311340193489413114LAVH CDS, Item Number: CDS983455C, Case UDI/GTIN: 40193489413114, Unit UDI/ , Lot Number: 22HBU206,22HBU964 1019532714398540195327143986GROTH VAGINAL CDS, Item Number: CDS984201T, Case UDI/GTIN: 40195327143986, Unit UDI/ , Lot Number: 22IBA054 1019348989992440193489899925MAJOR LITHOTOMY, Item Number: CDS985547N, Case UDI/GTIN: 40193489899925, Unit UDI/ , Lot Number: 22JBN433,22IBE548 1019532717150640195327171507MAJOR VAGINAL HARPER PACK-LF, Item Number: DYNJ0161768F, Case UDI/GTIN: 40195327171507, Unit UDI/ , Lot Number: 22IDC076,22IDA825,22IDA274 1088994205442840889942054429VAG. HYST TRAY-LF, Item Number: DYNJ0209066N, Case UDI/GTIN: 40889942054429, Unit UDI/ , Lot Number: 22JME324 1019532722568140195327225682VAGINAL HYSTERECTOMY PACK-LF, Item Number: DYNJ0373807K, Case UDI/GTIN: 40195327225682, Unit UDI/ , Lot Number: 22JBO175 1019532702436940195327024360HYSTERECTOMY PACK-LF, Item Number: DYNJ20485L, Case UDI/GTIN: 40195327024360, Unit UDI/ , Lot Number: 22IDA372 1088827776352440888277763525HYSTERECTOMY PACK, Item Number: DYNJ25971I, Case UDI/GTIN: 40888277763525, Unit UDI/ , Lot Number: 22JBO188 1019532714819540195327148196MAJOR ABD PROCEDURE PACK-LF, Item Number: DYNJ36731F, Case UDI/GTIN: 40195327148196, Unit UDI/ , Lot Number: 22IBA619 1088994221592840889942215929GYN PACK, Item Number: DYNJ40409C, Case UDI/GTIN: 40889942215929, Unit UDI/ , Lot Number: 22JBM950 1088827707326540888277073266BLADDER SLING PACK, Item Number: DYNJ43887, Case UDI/GTIN: 40888277073266, Unit UDI/ , Lot Number: 22JBN288,22IBD109 1019348972999340193489729994PERI/GYN PACK-RFD, Item Number: DYNJ48918J, Case UDI/GTIN: 40193489729994, Unit UDI/ , Lot Number: 22JMD314 1019348931376540193489313766ROBOT HYSTERECTOMY, Item Number: DYNJ49221C, Case UDI/GTIN: 40193489313766, Unit UDI/ , Lot Number: 22KMA208 1019348994422840193489944229VAG HYST, Item Number: DYNJ51386B, Case UDI/GTIN: 40193489944229, Unit UDI/ , Lot Number: 22IBJ500 1019348999694440193489996945GYN MAJOR PACK, Item Number: DYNJ52095I, Case UDI/GTIN: 40193489996945, Unit UDI/ , Lot Number: 22IDA203 1088994244460140889942444602VAGINAL HYSTER PROCEDURE, Item Number: DYNJ53804, Case UDI/GTIN: 40889942444602, Unit UDI/ , Lot Number: 22JDB955 - Amount recalled
- 1,258 cases (2,154 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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