Z-2649-2023Class II

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

Name: Z-2649-2023 Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2023-05-23
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2023-05-23 / Open, Classified / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case on 2023-05-23. FDA classified it as Class II and gives the reason as "The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect bell and base size". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2649-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-23
Posted: 2023-09-29
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.
Product code: HFX Clamp, Circumcision
Reason for recall: The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect bell and base size.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 106 units
Distribution: US Nationwide distribution.
Product codes and lots: Lot #2022032501, exp. 2026-12-31, UDI-DI - (01)10653160312956

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2649-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2649-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-09-29

Product code HFX

K890897Class IICenturion CirclampTri-State Hospital Supply Corp. / cleared 1989-03-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)