Recall Z-0544-2018— Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
Class II · Terminated
Class II FDA medical device recall by Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables, initiated 2017-06-27, terminated 2020-07-27. It names 2 FDA 510(k) clearances: K110883, K032432. Product: Laceration Tray, Catalog # 1892R1 Product Usage: Surgical procedure. Reason: BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification..
- Recalling firm
- Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-27
- Terminated
- 2020-07-27
- Firm location
- Hauppauge, NY, United States
510(k) clearances named in this recall
2 on FDA's record- K110883 — J-STYLE BONE MARROW BIOPSY / ASPIRATION NEEDLE WITH SNARE-IT MARROW ACQUISITION CANNULA
- K032432 — BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Laceration Tray, Catalog # 1892R1 Product Usage: Surgical procedure
Reason for recall
BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
Data sourced from openFDA. This site is unofficial and independent of the FDA.