Recalls / —
—#34807
Product
Standard and Custom Spinal Trays with 5% Lidocaine Hydrochloride 2 ml ampul
- FDA product code
- BSP — Needle, Conduction, Anesthetic (W/Wo Introducer)
- Device class
- Class 2
- Medical specialty
- Anesthesiology
- 510(k) numbers
- K820047
- Affected lot / code info
- Catalog number 333027 Lot number 60544516, Catalog number 333200 Lot number 60536446, Catalog number 333210 Lot numbers 60536450 and 60542855, Catalog number 333230 Lot number 60542857, Catalog number 333742 Lot numbers 60536470, 60544549, and 60544550, Catalog number 333752 Lot number 60544557, Catalog number 333852 Lot numbers 60536493 and 60544563, Catalog number 333861 Lot numbers 60517577 and 60517578, Catalog number 333872 Lot number 60544582, Catalog number 560074 Lot number 60537371, Catalog number 560123 Lot number 60549408, Catalog number 560130 Lot number 60549409, Catalog number 560156 Lot number 60547692, Catalog number 560176 Lot number 60537460, Catalog number 560214 Lot number 60563428, Catalog number 560269 Lot number 60540604, Catalog number 560327 Lot numbers 60537472 and 60549429, Catalog number 560386 Lot number 60549439, Catalog number 560397 Lot number 60527954, Catalog number 560399 Lot number 60540619, Catalog number 560408 Lot number 60537475, Catalog number 560436 Lot number 60549863, Catalog number 560485 Lot number 60540907, and Catalog number 560505 Lot number 60566553.
Why it was recalled
drug ampuls in kits contain particulates
Root cause (FDA determination)
Other
Action the firm took
The recalling firm/kit manufacturer issued a recall letter dated 7/8/04 to its customers informing them of the problem and to return the product.
Recalling firm
- Firm
- B. Braun Medical, Inc.
- Address
- 901 Marcon Blvd, Allentown, Pennsylvania 18109-9512
Distribution
- Distribution pattern
- The products were shipped to 145 medical facilities and 79 distributors nationwide. The products were also shipped to 6 government accounts in FL, NC, NY, OH, and PA.
Timeline
- Recall initiated
- 2004-07-06
- Posted by FDA
- 2004-09-09
- Terminated
- 2004-11-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #34807. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.