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Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw… recallZ-3093-2024 · MEDLINE INDUSTRIES, LP - Northfield · initiated May 7, 2024

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

Potential for an incomplete seal on the packaging tray.

FDA root cause category: Under Investigation by firm

What the company is doing

Medline notified consignees on about 05/06/2024 via letter sent email or First-Class mail. Consignees were instructed to examine inventory and quarantine any affected units, return any affected product that they may have on hand for credit or replacement, notify customers or personnel if the affected product was further distributed or transferred, and complete and return the response form.

Recall details

Recall number
Z-3093-2024
Status
Open, Classified
Initiated by the company
May 7, 2024
Posted by the FDA
Sep 10, 2024
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
2,860 units
Product code
NUJ
FDA submissions
K182588
Distribution
US Nationwide distribution.

Product description

Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37 cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1937CR.

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

Item Number: LF1937CR. UDI/DI: 20888277719412 (case), 10888277719415 (each). Lot Numbers: 487233, 487315, 500686, 500687, 500963, 507070, 507116, 507420, 507423, 507424, 513684, 513691, 513692, 513998, 513999, 514002, 514004, 514006, 514205, 514206, 514332, 514337, 514343, 514540, 514542, 514631, 514633, 514634, 514873, 514874, 514875, 514876, 514877, 514878, 514879, 514880, 514881, 514882, 514883, 514884, 514885, 514886, 514887, 514939, 515183, 515184, 515185, 515186, 515238, 515239, 515240, 515241, 515246, 515247, 515248, 515249, 515281, 515282, 515283, 515284, 515285, 515433, 515461, 515462, 515463, 515464, 515519, 515520, 515521, 515522, 515523, 515524, 515525, 515527, 515561, 515562, 515563, 515564, 515565, 515566, 515568, 515569, 515760, 515762, 515764, 515765, 515766, 515767, 515768, 515832, 515834, 515835, 515836, 515837, 515838, 515839, 515840, 515841, 515842, 515843, 515844, 515963, 515991, 515992, 515993, 515994, 515995, 515996, 515997, 516002, 516087, 516088, 516091, 516092, 516156, 516163, 516164, 516165, 516214, 516215, 516216, 516217, 516218, 516219, 516220, 516221, 516223, 516261, 516262, 516267, 516270, 516273, 516276, 516277, 516393, 516401, 516402, 516404, 516491, 516492, 516493, 516494, 516495, 516497, 516498, 516499, 516500, 516501, 516503, 516504, 516505, 516541, 516542, 516543, 516544, 516545, 516721, 516722, 516723, 516728, 516729, 516730, 516731, 516740, 516745, 516746, 516749, 516752, 516754, 516756, 516870, 516872, 516882, 516883, 517086, 517094, 517933, 517935, 517936, 517940, 517944, 517945, 518078, 518079, 518080, 518081, 518082, 518147, 518148, 518149, 518150, 518151, 518293, 518294, 518296, 518297, 518546, 518550, 518553, 518556, 518622, 518624, 518625.

Devices named in this recall

1 device 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 95126).

Sources and updates

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