| |
Class 2 Device Recall Custom Sterile and NonSterile Procedural Kits containing Turkuaz Ultrasound Gel |
 |
| Date Initiated by Firm |
May 15, 2023 |
| Date Posted |
August 03, 2023 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-2293-2023 |
| Recall Event ID |
92399 |
| Product Classification |
Spinal epidural anesthesia kit - Product Code OFT
|
| Product |
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following:
a.18G CPNB 20G STYLETED CATHETER, Model Number: DYNJRA1869;
b. ACUTE PAIN BLOCK TRAY, Model Number: DYNJRA0949C;
c. ANESTHESIA BLOCK KIT, Model Number: DYNJRA1864;
d. BLOCK KIT, Model Number: DYNJRA1893;
e. DR LEWIS US TRAY, Model Number: DYNJRA1998;
f. ECHOGENIC SINGLE SHOT TRAY, Model Number: DYNJRA1978, DYNJRA1978A, SAMPA0109;
g. FEMORAL BLOCK TRAY, Model Number: DYNJRA1739A;
h. NERVE BLOCK INSERTION, Model Number: DYNJRA2027;
i. NERVE BLOCK PREP TRAY, Model Number: DYNJRA1837;
j. NERVE BLOCK TRAY, Model Number: DYNJRA1878, DYNJRA1900;
k. NERVE PERIPHERAL PACK, Model Number: DYNJRA2055;
l. PAIN BLOCK TRAY, Model Number: DYNJRA0827A;
m. PAIN PREP TRAY W/PROBE COVER, Model Numbers: DYNJRA0881, DYNJRA1847, DYNJRA1975;
n. PAIN PREP W/ PROBE COVER TRAY, Model Number: DYNJRA2028;
o. PAIN PREP W/PROBE COVER TRAY, Model Number: PAIN1762;
p. PAIN TRAY, Model Number: DYNJRA1603;
q. PERIPHERAL NERVE CATHETER KT, Model Number: PAIN1560;
r. PREOP NERVE BLOCK TRAY, Model Number: DYNJRA2040;
s. PREP TRAY, Model Number: DYNJRA1498A;
t. SINGLE SHOT BLOCK, Model Number: DYNJRA0961B;
u. SINGLE SHOT NERVE BLOCK TRAY, Model Number: DYNJRA2077;
v. TAP BLOCK, Model Number: DYNJRA1823;
w. TRAY ULTRASOUND BLOCK 20G X 4, Model Number: DYNJRA9044;
x. TRAY 18G CPNB 20G STYLETED, Model Number: DYNJRA9040;
y. ULTRASOUND TRAY, Model Number: DYNJRA2022;
z. US TPI KIT, Model Number: DYNJRA1945
|
| Code Information |
All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023:
a. Model Number: DYNJRA1869; UPC Number: 019532701881.
b. Model Number: DYNJRA0949C; UPC Number: 019348966504.
c. Model Number: DYNJRA1864; UPC Number: 019348926312.
d. Model Number: DYNJRA1893; UPC Number: 019532706282.
e. Model Number: DYNJRA1998; UPC Number: 019532719429.
f. Model Number: DYNJRA1978, UPC Number: 019348926312; Model Number: DYNJRA1978A, UPC Number: 019532732040; Model Number: SAMPA0109, UPC Number: 019532709698.
g. Model Number: DYNJRA1739A; UPC Number: 019348992495.
h. Model Number: DYNJRA2027; UPC Number: 019532722522.
i. Model Number: DYNJRA1837. UPC Number: 019348997671.
j. Model Number: DYNJRA1878, UPC Number: 019532704037; Model Number: DYNJRA1900, UPC Number: 019532708225.
k. Model Number: DYNJRA2055, UPC Number: 019532725516.
l. Model Number: DYNJRA0827A, UPC Number: 019348921446.
m. Model Number: DYNJRA0881, UPC Number: 019348926312; Model Number: DYNJRA1847, UPC Number: 019348999366; Model Number: DYNJRA1975, UPC Number: 019532716324.
n. Model Number: DYNJRA2028, UPC Number: 019348926312.
o. Model Number: PAIN1762, UPC Number: 019348996209.
p. Model Number: DYNJRA1603, UPC Number: 019348929900.
q. Model Number: PAIN1560, UPC Number: 019348921538.
r. Model Number: DYNJRA2040, UPC Number: 019532724369.
s. Model Number: DYNJRA1498A, UPC Number: 019532712905.
t. Model Number: DYNJRA0961B, UPC Number: 019532726771.
u. Model Number: DYNJRA2077, UPC Number: 019532727891.
v. Model Number: DYNJRA1823, UPC Number: 019348996188.
w. Model Number: DYNJRA9044, UPC Number: 019348988811.
x. Model Number: DYNJRA9040, UPC Number: 019348983051.
y. Model Number: DYNJRA2022, UPC Number: 019532721816.
z. Model Number: DYNJRA1945, UPC Number: 019532713305.
|
Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact |
Karin Johnson
886-359-1704
|
Manufacturer Reason
for Recall |
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
|
FDA Determined
Cause 2 |
Nonconforming Material/Component |
| Action |
Medline notified customers beginning on 05/15/2023, via mail and email with letter. Customers with Medline Probe Cover Kits were instructed to check inventory for affected kits, destroy any affected kits, and complete and return the response form. Distributors were instructed to notify their customers and have them document and destroy affected kits. Customers with the non-sterile and sterile procedural kits were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits. Distributors were instructed to notify customers of the recall and have customers return any affected product for return to Medline.
Medline identified additional units of Medline Probe Cover Kits and notified customers on 06/22/2023. Customers were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits. |
| Quantity in Commerce |
29,277 kits |
| Distribution |
Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates. |
| 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.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
|
|
|
