Distribution Pattern
Worldwide distribution: US (nationwide) and countries of: Argentina, Australia, Austria, Azerbaijan, Bangladesh, Brazil, Bulgaria, Canada, Chile, China, Columbia, Ecuador, Egypt, France, Germany, Greece, Hungary, India, Indonesia, Israel, Italy, Ivory Coast, Japan, Kazakhstan, Latvia, Libya, Lithuania Malaysia, Morocco, Myanmar, Nepal, Philippines, Poland, Rumania, Russian Fed., Saudi Arabia, Senegal, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Uruguay, Vietnam, White Russia Turkmenistan.

Product Description
Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M used to administer anesthesia and ventilation to patients during surgical procedures.
0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045
Next Choice'' One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg, 1 Tablet/Blister Card (NDC 52544-287-54), Manufactured by Watson Laboratories Inc, 132 Business Center Drive, Corona, CA 92880.
Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bottle, Sandoz Inc., Princeton NJ, 08540, NDC 0781-1407-01.
Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX072003CL. The LifeStent Solo Vascular Stent System is intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and in the proximal popliteal artery with reference vessel diameters ranging from 4.0 6.5 mm.

Code Info
Lot 17-400-EV* and 17-401-EV * Note: the lot number may be followed by 01
Product Code:EX062001CL Lot Numbers: ANVG3284, ANVH2474, ANVJ1379, ANVJ2590, ANVK3364, ANVL2910, ANVG3862, ANVH2475, ANVJ2089, ANVK3149, ANVK3707, ANVH0592, ANVH3715, ANVK3150, ANVL2902. Product Code: EX062003CL Lot Numbers: ANVG3285 ANVH1962 ANVJ1385 ANVK3655 ANVL2915 ANWA1414 ANVG3286 ANVH2125 ANVJ1799 ANVL0001 ANWA0307 ANWA1415 ANVG3287 ANVH2126 ANVJ1800 ANVL0002 ANWA0308 ANWA1416 ANVG3882 ANVH2127 ANVJ1801 ANVL0169 ANWA0458 ANWA1419 ANVG3883 ANVH2185 ANVJ1802 ANVL0170 ANWA0459 ANWA3834 ANVG3884 ANVH2186 ANVJ1890 ANVL0364 ANWA0493 ANWA3855 ANVG3885 ANVH2187 ANVJ1891 ANVL0526 ANWA0494 ANWB0137 ANVH0325 ANVH2392 ANVJ1892 ANVL0527 ANWA0495 ANWB0139 ANVH0326 ANVH2393 ANVJ1893 ANVL0528 ANWA0698 ANWB1630 ANVH0327 ANVH3089 ANVJ2090 ANVL0811 ANWA0699 ANWB1631 ANVH0328 ANVH3278 ANVJ2091 ANVL0812 ANWA0701 ANWB1632 ANVH0329 ANVH3279 ANVJ2337 ANVL0813 ANWA0820 ANWD3081 ANVH0593 ANVH3434 ANVJ2591 ANVL0814 ANWA0821 ANWE1362 ANVH0594 ANVH3435 ANVK0075 ANVL1027 ANWA0857 ANWE1365 ANVH0596 ANVH3451 ANVK0076 ANVL1028 ANWA0858 ANWE1366 ANVH0597 ANVH3452 ANVK0077 ANVL1029 ANWA0859 ANWE1368 ANVH0598 ANVH3453 ANVK0078 ANVL1219 ANWA0964 ANWE2371 ANVH0997 ANVH3454 ANVK0474 ANVL1220 ANWA0965 ANWE2864 ANVH0998 ANVH3716 ANVK0552 ANVL1221 ANWA0966 ANWE3415 ANVH0999 ANVH3717 ANVK0755 ANVL1391 ANWA0967 ANWE3416 ANVH1000 ANVH3718 ANVK0756 ANVL1392 ANWA1125 ANWE3550 ANVH1001 ANVI0132 ANVK0871 ANVL1393 ANWA1373 ANWE3551 ANVH1002 ANVI0134 ANVK0872 ANVL1394 ANWA1384 ANWE3552 ANVH1182 ANVI0135 ANVK1133 ANVL1604 ANWA1385 ANWE3685 ANVH1183 ANVI0136 ANVK1134 ANVL1605 ANWA1388 ANWE3686 ANVH1184 ANVI0311 ANVK1253 ANVL1608 ANWA1390 ANWE3982 ANVH1185 ANVI0808 ANVK1461 ANVL1609 ANWA1391 ANWE4134 ANVH1186 ANVI0967 ANVK1462 ANVL1762 ANWA1395 ANWE4135 ANVH1187 ANVI1251 ANVK1463 ANVL1763 ANWA1396 ANWE4136 ANVH1188 ANVI1252 ANVK1669 ANVL1764 ANWA1397 ANWF0178 ANVH1189 ANVI2510 ANVK1670 ANVL1765 ANWA1398 ANWF0179 ANVH1190 ANVI2511 ANVK1671 ANVL2346 ANWA1399 ANWF0180 ANVH1191 ANVI2513 ANVK1982 ANVL2347 ANWA1400 ANWF0370 ANVH1324 ANVI2514 ANVK1983 ANVL2687 AN

Reason for Recall
During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia machines, some units did not pass the high voltage test and the minimum clearance between an electrical component and the unit housing was not maintained for some from a specific batch.
Lack of Assurance of Sterility; potential for vial breakage
Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.
Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.
Bard Peripheral Vascular is recalling specific lots of Bard Lifestent Solo Vascular Stent because they have determined a higher incidence rate of partial stent deployment associated with their use.