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FDA (Device enforcement)Recalled 2021-08-24closedclass ii

Bard Peripheral Vascular Inc: Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single Use Only, RX only. Exp. Date Lidocaine Vendor lot

Is my product affected?

Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion Intended use to aspirate marrow from either the sternum or the iliac crest. Intraosseous Infusion is recommended only

  • UPC 50885403057258

Check against the official notice below — it lists the full affected range.

What happened

Bard Peripheral Vascular Inc. is recalling 360 units of its Economy Jamshidi Bone Marrow Biopsy Tray (Catalog # BEK3411) containing sterile 11G x 4" biopsy/aspiration needles. The recall was issued because misbranded products were shipped to customers. The affected devices were distributed across 16 U.S. states and Puerto Rico, with a manufacturing date of August 19, 2020, and expiration date of December 31, 2021.

The recalled lot number is 0001378561. The source document does not specify what remedy consumers should take if they have received this product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Due to misbranded products shipped to customers.

Details from the source

Reason for recall: Due to misbranded products shipped to customers. Distribution: U.S. Distribution: CA, GA,HI, IL, IN, LA, MO, MS, NC, OH, PA, PR, TX, UT, VA, and WA. OUS: None Quantity: 360 devices Lot/code info: Cat No.: BEK3411; Lot /Serial No.: 0001378561; UDI # BEK3411, Lot BEK3411, Lot BEK3411, Lot 0001378561; (01)50885403057258(17)211231(10)0001378561; Mfg. Date 08/19/2020; Exp. Date: 12/31/2021; Qty: 360

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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