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

FDA device recall Z-2649-2023 · posted 2023-09-29 · Open, Classified

Recall details

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Reason for recall

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

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

HFX

Quantity affected

106 units

Distribution

US Nationwide distribution.

Date initiated

2023-05-23

Date posted

2023-09-29

Location

Northfield, IL

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