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Sterile Procedural Trays, labeled as the following recallZ-1093-2023 · MEDLINE INDUSTRIES, LP - Northfield · initiated Nov 17, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Device Design

What the company is doing

Medline Industries, LP notified consignees via email and first-class mail on 11/15/2022. Consignees were instructed to check stock for affected product and immediately quarantine. For any affected units, customers were instructed to over-label the sterile kits with a warning label indicating "Warning To Avoid Injury, Please Handle Blades with Care." No product is to be returned. Customers were also instructed to complete and return the response form and notify customers if further distributed.

Recall details

Recall number
Z-1093-2023
Status
Open, Classified
Initiated by the company
Nov 17, 2022
Posted by the FDA
Feb 6, 2023
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
1,258 cases (2,154 units)
Product code
OJF
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

Product description

Sterile Procedural Trays, labeled as the following: a. 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

Code information (models, lots, serial numbers)

Show the full code information (4k characters)

a. GYN ABD CDS, Item Number: CDS830215G, Case UDI/GTIN: 40889942110040, Unit UDI/GTIN: 10889942110049, Lot Number: 22IMD263; b. LAVH PROCEDURE, Item Number: CDS980754R, Case UDI/GTIN: 40195327008698, Unit UDI/GTIN: 10195327008697, Lot Number: 22JME637; c. TAH CDS, Item Number: CDS982249I, Case UDI/GTIN: 40193489651264, Unit UDI/GTIN: 10193489651263, Lot Number: 22JBM626,22JBK303; d. CUH LITHOTOMY CDS, Item Number: CDS983207M, Case UDI/GTIN: 40195327164608, Unit UDI/GTIN: 10195327164607, Lot Number: 22JBM359; e. LAVH CDS, Item Number: CDS983455C, Case UDI/GTIN: 40193489413114, Unit UDI/GTIN: 10193489413113, Lot Number: 22HBU206,22HBU964; f. GROTH VAGINAL CDS, Item Number: CDS984201T, Case UDI/GTIN: 40195327143986, Unit UDI/GTIN: 10195327143985, Lot Number: 22IBA054; g. MAJOR LITHOTOMY, Item Number: CDS985547N, Case UDI/GTIN: 40193489899925, Unit UDI/GTIN: 10193489899924, Lot Number: 22JBN433,22IBE548; h. MAJOR VAGINAL HARPER PACK-LF, Item Number: DYNJ0161768F, Case UDI/GTIN: 40195327171507, Unit UDI/GTIN: 10195327171506, Lot Number: 22IDC076,22IDA825,22IDA274; i. VAG. HYST TRAY-LF, Item Number: DYNJ0209066N, Case UDI/GTIN: 40889942054429, Unit UDI/GTIN: 10889942054428, Lot Number: 22JME324; j. VAGINAL HYSTERECTOMY PACK-LF, Item Number: DYNJ0373807K, Case UDI/GTIN: 40195327225682, Unit UDI/GTIN: 10195327225681, Lot Number: 22JBO175; k. HYSTERECTOMY PACK-LF, Item Number: DYNJ20485L, Case UDI/GTIN: 40195327024360, Unit UDI/GTIN: 10195327024369, Lot Number: 22IDA372; l. HYSTERECTOMY PACK, Item Number: DYNJ25971I, Case UDI/GTIN: 40888277763525, Unit UDI/GTIN: 10888277763524, Lot Number: 22JBO188; m. MAJOR ABD PROCEDURE PACK-LF, Item Number: DYNJ36731F, Case UDI/GTIN: 40195327148196, Unit UDI/GTIN: 10195327148195, Lot Number: 22IBA619; n. GYN PACK, Item Number: DYNJ40409C, Case UDI/GTIN: 40889942215929, Unit UDI/GTIN: 10889942215928, Lot Number: 22JBM950; o. BLADDER SLING PACK, Item Number: DYNJ43887, Case UDI/GTIN: 40888277073266, Unit UDI/GTIN: 10888277073265, Lot Number: 22JBN288,22IBD109; p. PERI/GYN PACK-RFD, Item Number: DYNJ48918J, Case UDI/GTIN: 40193489729994, Unit UDI/GTIN: 10193489729993, Lot Number: 22JMD314; q. ROBOT HYSTERECTOMY, Item Number: DYNJ49221C, Case UDI/GTIN: 40193489313766, Unit UDI/GTIN: 10193489313765, Lot Number: 22KMA208; r. VAG HYST, Item Number: DYNJ51386B, Case UDI/GTIN: 40193489944229, Unit UDI/GTIN: 10193489944228, Lot Number: 22IBJ500; s. GYN MAJOR PACK, Item Number: DYNJ52095I, Case UDI/GTIN: 40193489996945, Unit UDI/GTIN: 10193489996944, Lot Number: 22IDA203; t. VAGINAL HYSTER PROCEDURE, Item Number: DYNJ53804, Case UDI/GTIN: 40889942444602, Unit UDI/GTIN: 10889942444601, Lot Number: 22JDB955; u. TLH PACK, Item Number: DYNJ63145A, Case UDI/GTIN: 40193489979573, Unit UDI/GTIN: 10193489979572, Lot Number: 22JBN742,22IBK842; v. TLH PACK, Item Number: DYNJ80430, Case UDI/GTIN: 40195327038473, Unit UDI/GTIN: 10195327038472, Lot Number: 22HBN532; w. VAG HYST PACK, Item Number: DYNJ82634, Case UDI/GTIN: 40195327199563, Unit UDI/GTIN: 10195327199562, Lot Number: 22JBY522; x. LITHOTOMY-LF, Item Number: DYNJ900721C, Case UDI/GTIN: 40193489951609, Unit UDI/GTIN: 10193489951608, Lot Number: 22KBC673; y. MAJOR LITHOTOMY, Item Number: DYNJ902373I, Case UDI/GTIN: 40195327224760, Unit UDI/GTIN: 10195327224769, Lot Number: 22JBO747; z. LAVH, Item Number: DYNJ903392F, Case UDI/GTIN: 40193489467506, Unit UDI/GTIN: 10193489467505, Lot Number: 22JBR451; aa. LAVH, Item Number: DYNJ904335B, Case UDI/GTIN: 40193489926720, Unit UDI/GTIN: 10193489926729, Lot Number: 22JBU057; bb. D&C / GYN, Item Number: DYNJ906514B, Case UDI/GTIN: 40193489998567, Unit UDI/GTIN: 10193489998566, Lot Number: 22IBP589,22IBD796; cc. LAPAROSCOPIC HYSTERECTOMY, Item Number: DYNJ906844A, Case UDI/GTIN: 40195327025954, Unit UDI/GTIN: 10195327025953, Lot Number: 22JMG630; dd. FS LAP TUBAL LIGATION, Item Number: DYNJ908306, Case UDI/GTIN: 40195327030316, Unit UDI/GTIN: 10195327030315, Lot Number: 22KBE781,22JBO684; ee. LAVH, Item Number: DYNJQ9041Q, Case UDI/GTIN: 40193489850605, Unit UDI/GTIN: 10193489850604, Lot Number: 22JBG106,22IBB420,22IBC141; ff. ABD HYST PACK-LF, Item Number: DYNJT1912G, Case UDI/GTIN: 40888277809056, Unit UDI/GTIN: 10888277809055, Lot Number: 22HBW646; gg. VAG HYST PK-LF, Item Number: DYNJT1913J, Case UDI/GTIN: 40193489976473, Unit UDI/GTIN: 10193489976472, Lot Number: 22IBQ666,22HBU577

Devices named in this recall

34 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 91386).

Sources and updates

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