CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, Custom Epidural and Anesthesia Tray, Custom Epidural Anesthesia Tray, Custom Kit, Custom Single Dose Epidural Anesthesia Tray, Custom Spinal Anesthesia Tray, Custom Spinal Epidural Anesthesia Tray, ESPOCAN Combined Spinal and Epidural Anesthesia Tray, PERIFIX Continuous Epidural Anesthesia Tray, PERIFIX FX Continuous Epidural Tray, PERIFIX One Continuous Epidural Pediatric Tray; Utilization of Product: Injection of local anesthetics to provide regional anesthesia for pain management. Route of administration is injection into subarachnoid space or epidural space or tissue surrounding peripheral nerve bundle(s). Custom Epidural and Anesthesia Tray
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product codes: 331706 332128 331756 551474 551572 551727 551749 551769 551771 551773 551858 551889 551922 551942 552011 555098 555170 555215 555217 555325 555422 530132 530155 551273 551845 551970 551992 555212 555876 560123 560473 530035 530068 333194 333192 332211 332282 332079 332097 332086 332292 Batch Numbers: 61415053 61416382 61416362 61415022 61414464 61415024 61416390 61415028 61415921 61415924 61415023 61414468 61415044 61415051 61415037 61411483 61418020 61418077 61416399 61415041 61416385 61414419 61414589 61415712 61412398 61413393 61414485 61414481 61414591 61417210 61412387 61415001 61415013 61418035 61414411 61413390 61416395 61414492 61415040 61414417 61411528 61415708 expiration dates: 7/31116 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 6/30/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 1/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 9/30/16 7/31/16 6/30/16 6/30/16 3/31/17 2/28/17 7/31/16 7/31/16 7/31/16 1/31/18 7/31/16 7/31/16 6/30/16 7/31/16 2/28/17 6/30/16 1/31/17
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- B. Braun Medical, Inc.
- Reason for Recall:
- There is a potential for a hole to be present in the outer tray of a limited number of pain control trays. This issue may cause the integrity of the sterile barrier to be compromised. A compromised sterile barrier poses a risk of inflammatory response and/or possible contamination of the spinal fluid or epidural space.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, Custom Epidural and Anesthesia Tray, Custom Epidural Anesthesia Tray, Custom Kit, Custom Single Dose Epidural Anesthesia Tray, Custom Spinal Anesthesia Tray, Custom Spinal Epidural Anesthesia Tray, ESPOCAN Combined Spinal and Epidural Anesthesia Tray, PERIFIX Continuous Epidural Anesthesia Tray, PERIFIX FX Continuous Epidural Tray, PERIFIX One Continuous Epidural Pediatric Tray; Utilization of Product: Injection of local anesthetics to provide regional anesthesia for pain management. Route of administration is injection into subarachnoid space or epidural space or tissue surrounding peripheral nerve bundle(s). Custom Epidural and Anesthesia Tray
Product Codes/Lot Numbers:
Product codes: 331706 332128 331756 551474 551572 551727 551749 551769 551771 551773 551858 551889 551922 551942 552011 555098 555170 555215 555217 555325 555422 530132 530155 551273 551845 551970 551992 555212 555876 560123 560473 530035 530068 333194 333192 332211 332282 332079 332097 332086 332292 Batch Numbers: 61415053 61416382 61416362 61415022 61414464 61415024 61416390 61415028 61415921 61415924 61415023 61414468 61415044 61415051 61415037 61411483 61418020 61418077 61416399 61415041 61416385 61414419 61414589 61415712 61412398 61413393 61414485 61414481 61414591 61417210 61412387 61415001 61415013 61418035 61414411 61413390 61416395 61414492 61415040 61414417 61411528 61415708 expiration dates: 7/31116 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 6/30/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 1/31/16 7/31/16 7/31/16 7/31/16 7/31/16 7/31/16 9/30/16 7/31/16 6/30/16 6/30/16 3/31/17 2/28/17 7/31/16 7/31/16 7/31/16 1/31/18 7/31/16 7/31/16 6/30/16 7/31/16 2/28/17 6/30/16 1/31/17
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1576-2015
Related Recalls
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huon Co, Ltd., has issued a voluntary recall due to potential quality issues identified during a recent FDA manufacturing facility inspection.
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.