Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).
Reason for recall: Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles). Distribution: Worldwide distribution - U.S. Nationwide in the states of IL and TX. The countries of ALBANIA, ARMENIA, AUSTRALIA, AZERBAIJAN, BAHRAIN, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, EGYPT, FRANCE, GEORGIA, GERMANY, GREECE, HONG KONG, HUNGARY, INDONESIA, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA REPUBLIC OF, KOSOVO, KUWAIT, LUXEMBOURG, MALAYSIA, MEXICO, MOLDOVA REPUBLIC OF, Quantity: 462 Lot/code info: Lot Code: Model number: EG-121, UDI: 07613353180287 Lot number: 16457-10, Expiry date: 2026-04 Model number: EG-121, UDI: 07613353180287 Lot number: 16457-80, Expiry date: 2026-04 Model number: EG-121, UDI: 07613353180287 Lot number: 16457-120, Expiry date: 2026-07 Model number: EG-121, UDI: 07613353180287 Lot number: 16457-130, Expiry date: 2026-10 Model number: EG-121, UDI: 07613353180287 Lot number: 16457-140, Expiry date: 2026-10 Model number: EG-121, UDI: 07613353180287 Lot number: 16866-80, Expiry date: 2026-10: batch not impacted by the deviation, but as the expiry date is the same than other batches impacted it was decided to recall this batch as well because the expiry date is engraved on the bottles and the user might not be able to differentiate the batch number if the packaging was disposed of. AIRFLOW Prophylaxis Master UDI-DI codes: 07613353213183 and 07613353184148 AIRFLOW ONE UDI-DI code: 07613353184124 Product Serial Numbers: LD04753 LD04757 LG10166 LG10167 LG10168 LG10169 LG10170 LG10171 LG10172 LG10173 LG10174 LG10175 LG10151 LG10152 LG10153 LG10154 LG10155 LG10156 LG10157 LG10158 LG10159 LG10160 LG10161 LG10162 LG10163 LG10164 LG10165 OF-04-05367-1 LG10413 LG10414 LG10416 LG10418 LG10421 LG11050 LG11051 LG11052 LG11053 LG11054 LG11055 LG11056 LG11057 LG11127 LG11128 LG11129 LG11130 LG11131 LG11132 LG11133 LG11134 LG11135 LG11136 LG11313 LG11314 LG11315 LG11316 LG11317 LG11318 LG11319 LG11320 LG11321 LG11322 LG11323 LG11324 LG11325 LG11326 LG11327 LG11328 L
07613353180287, 07613353213183, 07613353184148, 07613353184124
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.