Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Reason for recall: Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Om Quantity: 4348 units Lot/code info: a) DBM T600106 XPANSE SMALL-C 6, REF T600106, GTIN 00643169218314, Serial Numbers: A41747-061, A41747-062, A41747-063, A41747-064, A41747-065, A41747-066, A41747-067, A41747-068, A41747-069, A41747-070, A41747-071, A41747-072, A41747-073, A43745-061, A43745-062, A43745-063, A43745-064, A43745-065, A43745-066, A43745-067, A43745-068, A43745-069, A43745-070, A43745-071, A43745-072, A43745-073, A43745-074, A43745-075, A43748-036, A43748-037, A43748-038, A43748-039, A43748-040, A46458-036, A46458-037, A46458-038, A46458-039, A46458-040, A46458-041, A46458-042, A46458-043, A46458-044, A46458-045, A46458-046, A46458-047, A46458-048, A49576-028, A49576-029, A49576-030, A49576-031, A49576-032, A49576-033, A49576-034, A49576-035, A49576-036, A49576-037, A49576-038, A49576-039, A49576-040; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206, GTIN 00643169218352, Serial Numbers: A38618-078, A38618-079, A38618-080, A38618-081, A38618-082, A38618-083, A38618-084, A38618-085, A38618-086, A38618-087, A38618-088, A38618-089, A38618-090, A38618-091, A38618-092, A38618-093, A38618-094, A38618-095, A38618-096, A38618-097, A38618-098, A38618-099, A38618-100, A38618-101, A38618-102, A38618-103, A38618-104, A38618-105, A38618-106, A38618-107, A38618-108, A38618-109, A38618-110, A38618-111, A38618-112, A38618-113, A38618-114, A38618-115, A38618-116, A38618-117, A38618-118, A38618-119, A38618-120, A38618-121, A38618-122, A38618-123, A38618-124, A38618-125, A38618-126, A38618-127, A38618-128, A38618-129, A
00643169218314, 00643169218352, 00643169218376, 00643169218390
Official record: FDA (Device enforcement) ↗
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