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Centurion Sterile CirClamp with 1.45cm Bell Reprocessed… recallZ-2649-2023 · MEDLINE INDUSTRIES, LP - Northfield · initiated May 23, 2023

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

The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect bell and base size.

FDA root cause category: Process control

What the company is doing

The recalling firm issued letters dated 5/23/2023 via email and first class mail on 5/23/2023 to its consignees, which identified incorrect information regarding the affected product. It had stated the label indicates the kit contains a 1.3 cm bell and insert; however the kit actually contains a 1.45 cm bell and insert. The affected kits were to be destroyed for credit and none were to be returned to the recalling firm. The consignee was to check their stock for the affected item number and lot numbers listed on the recalling firm's recall portal and destroy the affected product. A link was provided to complete the response form. If the consignee is a distributor or has resold or transferred the product to another company or individual, they are to notify them of this recall communication. The recalling firm issued a letter flagged as an Amended Letter dated 9/1/2023 via email and first class mail that alerted the consignee to the incorrect product information contained in the initial 5/23/2023 letter and the Amended Letter provided the correct product information, that being the product is supposed to include a 1.45 cm base and 1.45cm bell, however, the kit incorrectly contains CirClamp subassembly 345CRSAK which includes a 1.6cm base and 1.6cm bell. The letter instructs that affected kits can be destroyed for credit and no kits are to be returned to Medline. The consignee is instructed to immediately check their stock for the item number and lot number listed in the letter and on the destruction form, quarantine the affected product, and destroy it. The enclosed destruction form listing the quantity of affected product destroyed is to be returned. If the product has been transferred to another individual, department or location , the consignee is to notify them of this recall communication.

Recall details

Recall number
Z-2649-2023
Status
Open, Classified
Initiated by the company
May 23, 2023
Posted by the FDA
Sep 29, 2023
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
106 units
Product code
HFX
FDA submissions
K890897
Distribution
US Nationwide distribution.

Product description

Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.

Code information (models, lots, serial numbers)

Lot #2022032501, exp. 2026-12-31, UDI-DI - (01)10653160312956

Devices named in this recall

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

Other devices under the same FDA submission

14 devices cleared under K890897 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page