| | Class 3 Device Recall EXACTAMED Oral Dispenser Pharmacy Pack |  |
| Date Initiated by Firm | June 27, 2019 |
|---|
| Create Date | August 29, 2019 |
|---|
| Recall Status1 |
Terminated 3 on November 02, 2020 |
| Recall Number | Z-2432-2019 |
|---|
| Recall Event ID |
83230 |
| Product Classification |
Dispenser, liquid medication - Product Code KYX
|
| Product | EXACTAMED Oral Dispensers, 5mL, AMBER:
PHARMACY PACK, REF H9388505, x500
PHARMACY PACK, REF H9388105, x100
COST CONTAINMENT, REF H93884205, x1500 |
|---|
| Code Information |
REF H9388105, Lot Numbers: B301N017P, B301N070P, B302M338P, B304N045P REF H9388505, Lot Numbers: B301N023P, B301N049P, B302N077P REF H93884205, Lot Numbers: B301N056P, B302M333P, B303N042P, B307N015P |
Recalling Firm/
Manufacturer |
Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
|
| For Additional Information Contact | Center for One Baxter
800-422-9837 |
|---|
Manufacturer Reason
for Recall | EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | The firm disseminated a safety alert to their consignees on 06/27/2019 by letter. The letter explained the 5mL syringes were commingled with 10mL syringes and directed the consignee separate the 5mL syringes from the 10mL syringes. |
|---|
| Quantity in Commerce | 2192000 syringes |
|---|
| Distribution | Nationwide |
|---|
| 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
|
|
|
