| Class 2 Device Recall Chest Tube Insertion Tray | |
Date Initiated by Firm | March 23, 2021 |
Create Date | May 20, 2021 |
Recall Status1 |
Completed |
Recall Number | Z-1623-2021 |
Recall Event ID |
87636 |
Product Classification |
Kit, surgical instrument, disposable - Product Code KDD
|
Product | Bioseal, Chest Tube Insertion Tray, containing ChloraPREP Applicator 3 mL, REF: CHT017/20, Sterile EO, Single Use Only, UDI: (01)10630094820177 |
Code Information |
Affected Lot Numbers: 400566, 400561, 400548, 400528 |
Recalling Firm/ Manufacturer |
Bioseal Corporation 167 W Orangethorpe Ave Placentia CA 92870-6922
|
For Additional Information Contact | Customer service 800-441-7325 |
Manufacturer Reason for Recall | Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity. |
FDA Determined Cause 2 | Unknown/Undetermined by firm |
Action | On 3/23/21, Bioseal emailed an "Urgent: Medical Device Recall" notice to affected consignees. In addition to informing consignees about the recall the firm ask consignees to take the following actions:
1. Please discontinue use of the product listed above.
2. Please complete enclosed response form listing the quantity of affected product on hand via email to recalls@biosealnet.com. Even if you do not have the affected product please complete and return the form. Once we have received the completed form we will forward product return information, if applicable.
3. If you have transferred possession of the product to another organization, you are required by FDA regulations to notify them of this recall communication. Please have any affected product returned to you for collection and return to Bioseal as specified above.
4. Adverse reactions or quality problems experience with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program.
5. If you have any questions regarding this matter, please contact customer service at 800-441-7325, Monday-Friday 8:00 AM - 5:00 PM P.S.T. |
Quantity in Commerce | 140 units |
Distribution | US: IL and MO
OUS: None |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
|
|
|
|