—#202810

Product

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

FDA product code: HFX — Clamp, Circumcision
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
510(k) numbers: K890897
Affected lot / code info: Lot #2022032501, exp. 2026-12-31, UDI-DI - (01)10653160312956

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2023-05-23
Posted by FDA: 2023-09-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #202810. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.